<iframe src="https://www.googletagmanager.com/ns.html?id=GTM-WR9VRVQ" height="0" width="0" style="display:none;visibility:hidden">

medical information

Delivering accurate information for patient health and safety.

Medical information flywheel heading logo.
Medical information flywheel heading mobile logo.
Colorized half circle.
Medical information consultant in front of medical information flywheel icon

Comprehensive Medical Information Services

With strategically positioned and seamlessly integrated contact centers around the world, we provide customizable medical information services to meet the needs of companies of all sizes. Whether you need adverse event intake and follow-up, medical writing and content management solutions, promotional review, or other extended medical information services, our team of medical information specialists have the knowledge and experience to effectively support your needs.

Medical Information Solutions:

Our innovative, market-leading technologies, and 24/7/365 contact centers allow us to provide best-in-class medical information services.

 

Global Contact Center Support

ProPharma's Medical Information (MI) Contact Center services “follow the sun,” providing 24-hour services for pharmaceutical companies. Our team is comprised of experienced healthcare professionals (HCPs) and life science graduates who act as an extension of your team, communicating essential product information in the areas of drug/device information and product safety.

Medical Information support personnel wearing headsets

 

Global 24/7/365 Contact Center Support

We offer 24/7/365 contact center support for first-line, second-line, and triage MI in both dedicated and shared models. We support your patients and your organization with expert handling of all MI requests, adverse event (AE) intake, and product quality complaint (PQC) intake.

Bilingual Native Speakers

Our team of highly trained MI specialists includes bilingual native speakers in more than 35 languages. With 8 strategically positioned and globally integrated contact centers around the world, we can respond to medical inquiries in a manner that is not only consistent with product labeling and regulatory guidance, but also consistent with local evidence, culture, and communication styles.

After Hours Services

As a "follow the sun" provider of MI services, we operate at full capacity beyond normal business hours providing you with around the clock, global support services.

Talk to an Expert

Woman smiling while wearing a headset

Adverse Event Intake and Follow-up Services

ProPharma’s Medical Information (MI) team is trained on Adverse Event (AE) intake since onboarding as part of MI processing. We ensure that every AE is collected for patients’ safety, customer journey, and compliance at every contact center exchange and sent to the designated pharmacovigilance (PV) department. For a seamless experience, ProPharma offers comprehensive AE processing and reporting through our dedicated PV team to supplement or fully outsource your existing PV function.

Comprehensive AE Intake

Our skilled specialists follow established global processes and guidelines to obtain timely, accurate, and comprehensive AE information. ProPharma conducts refresher training, regular updates, and quality monitoring to ensure that every AE is detected and delivered to PV within 1 business day. Our AE collection forms can be customized for your needs in our fully validated database and our specialists are experienced with various client databases and AE forms.

Man showing co-worker something on their computer monitor

Adverse Event Follow-up

Our experienced MI team is fully equipped to execute outbound follow-up communication and collect additional data that was not available at initial intake, which lessens the burden on your pharmacovigilance department.

Seamless Integration to Pharmacovigilance

All AE records automatically migrate from MI to the PV database within ProPharma, and you can review and monitor all cases from beginning to end in a single-point access 24/7. ProPharma can also integrate (E2B) with your PV database for the seamless and timely transfer of AE records.

Talk to an Expert

Product Complaint Intake and Follow-Up Services

ProPharma’s MI team is trained on Product Quality Complaint (PQC) intake since onboarding as part of MI processing. We ensure that every PQC is collected for patients’ safety, customer journey, and compliance at every contact center exchange and sent to the designated quality department. We are dedicated to supporting your customers and patients by handling every PQC and your company’s reputation with empathy and care.

Comprehensive PQC Intake

As your trusted MI partner, our highly trained specialists follow established global processes and guidelines for handling PQC events, to meet regulatory reporting requirements as well as your company’s own internal quality and manufacturing standards. ProPharma conducts refresher training, regular updates, and quality monitoring to ensure that every PQC is detected and delivered to the quality department within 1 business day. Our PQC collection forms can be customized for your needs in our fully validated database and our specialists are experienced with various client databases and PQC forms.

Physician using a tablet

Global Quality Serialization and Product Surety

We work collaboratively with our clients to offer centralized solutions for Global Quality Serialization and Product Surety (Level 5 Alerts), compliant with EU FMD and US DSCSA. Our skilled staff have extensive experience with the alerts that are generated within the European Medicines Verification System (EMVS), detected by a national system, which are escalated to other stakeholders, including National Competent Authorities (NCAs) as they are generated. Our experienced team are also fully equipped to follow the process requirements for triage, follow-up, and closure of any Product Quality Serialization Verification requests. The intent of the requirements for reporting Level 5 Alerts set out in the Falsified Medicines Directive is to protect patient safety. Therefore, we ensure that our approach is pragmatic, effective, efficient, and solely focused on you and your patients.

Explore DSCSA Compliance and Serialization Services
Medcial professional using laptop

Product Retrieval

Our specialists communicate product retrieval instructions as well as company policies regarding product replacement or reimbursement requests. We can also create a product retrieval kit and logistics to provide to the customers to return the products to your quality department or manufacturer.

Talk to an Expert

Patient Support Programs

ProPharma partners closely with internal teams to support our clients’ customers and patients to provide first-in-class global Patient Support Programs. Our diverse team of global contact centers and field partners support patients and healthcare professionals worldwide in obtaining, understanding, and adhering to therapies for a well-rounded customer journey.

Patient Assistance

ProPharma helps patients initiate and adhere to therapy by attenuating the financial burden, facilitating reimbursement, and providing outreach and support. We support both specialist-to-patient interaction and digital offerings to buttress the need of diverse patient demographics. Our customized solution can increase therapy adoption, patient engagement, and adherence, helping your goal to improve patients’ health.

Patient Education

ProPharma’s subject matter experts (SMEs) in the breadth of therapeutic areas aid patients with comprehending the disease state and medication or device use. We create and provide materials that translate complex information into easy to digest content with visuals to supplement the compassionate interaction with the specialists.

Health professional assisting a patient with a mobile device

 

Provider Support

ProPharma supplies providers with materials for patient education, such as handouts and mock devices, to better serve their patients. We also provide helpful information to guide patients to therapy decisions by overcoming access or financial barriers. ProPharma is dedicated to ensuring that your customers are supported in all avenues.

Talk to an Expert

Medical Communications, Content Management & Translation

Medical writing is an essential part of clinical research, which requires expert knowledge to analyze and prepare complex regulatory documents.

ProPharma is a global leader in pharmaceutical consulting with over 35 years of experience, and our medical writing team has the expertise to assist with the development of your product. Our team of writers, editors, and quality reviewers knows what it takes to produce clear, concise text for your clinical, scientific, and regulatory needs.

No matter where you are in the development process, we can act as an extension of your team to support your initiatives and achieve successful outcomes.

Standard Document Creation

Our query management services include developing and updating libraries of standard response documents, sourcing and supplying clinical papers, and writing safety summaries. Our team of bilingual, native-speaking medical professionals can create or translate key standard documents in more than 35 local languages.

Custom Response and Content Management

Clients turn to ProPharma for quality and affordable custom response documents, delivered in a timely manner. Our team has experience in all therapeutic areas, with backgrounds in both the life science industry and academia. We provide a full range of content services, including literature research, writing custom response documents, and adapting documentation for use in other geographies.

Response Document Maintenance

We understand the importance of keeping your documents up to date with strict version control to provide the most accurate responses to inquiries. We work with your teams to take this burden off your hands, with efficient document management processes that our clients trust and rely on.

Translation and Localization Services

We support your internal teams by creating new standard response documents, generating custom responses, and translating existing global and/or regional documents into one of over 35 supported languages. Our knowledgeable staff of bilingual native speakers leverage their extensive medical and communications experience to create effective documents that are consistent with local evidence, culture, and communication styles.

Tablet and stethoscope on a table

Medical Writing Services

From general guidance on strategy and formatting to specific projects like submissions and assessments — we can support your organization and adapt to changing needs throughout the development process.

Clinical and Nonclinical Medical Writing

  • Benefit-risk assessments and Risk Management Plans (RMPs)
  • Biologics License Applications (BLAs)
  • Clinical Study Reports (CSRs) and narratives
  • New Drug Applications (NDAs) (505)(b)(1) and 505(b)(2) submissions
  • NDAs Modules 1-5
  • Regulatory responses to questions
  • Investigational New Drug Applications (INDs) and Investigational Device Exemption Applications (IDEs)
  • Clinical Trials Disclosure (CTD) and authoring of plain language documents
  • Chemistry, Manufacturing, and Controls (CMC) materials
  • Drug Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • General investigational plans
  • Informed consent forms
  • Investigator’s Brochure (IB)
  • Medical device Clinical Evaluation Reports (CERs)
  • Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs)
  • Lifecycle management
  • Protocols and amendments
  • Orphan Drug Designation (ODD)/Breakthrough Designation
  • Pre-meeting packages (PMPs)/briefing packages
  • Ethnic Sensitivity Reports
  • Immunogenicity Reports

Project Support

  • Compilation, hyperlinking, and publishing
  • Comprehensive project management
  • Content editing and proofreading: Including a QC review of data against text and source documents
  • Style guide and template creation
  • Literature searches, analysis, reference libraries, and citations
  • Standard operating procedure (SOP) development
  • Build figures and populate tables

Publications

  • Abstracts, Manuscripts, and White Papers
  • Continuing Medical Educations (CME) program planning
  • Publication strategy


Talk to an Expert

Medical Information Experts

Rajul Jain

Rajul Jain

President
Medical Information

Dave Bezick

David Bezick

Director
Medical Information

Hannah Hunter

Hannah Hunter

Director
Medical Information

Katie Tonge

Katie Tonge

Director
Medical Information

Leanne Shaw

Leanne Shaw

Senior Director
Medical Information

Valerie Huh

Valerie Huh

Associate Director
Global Innovation

Victoria Evans

Victoria Evans

Director
Medical Information

News & Insights

FDA Regulatory Sciences The Impact of a US Government Shutdown on the Food and Drug Administration

September 27, 2023

The Impact of a US Government Shutdown on the Food and Drug Administration

U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Quality & Compliance Medical Information DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

September 25, 2023

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

Meet the Expert Medical Information Meet the Expert: Kamila Rocha

September 21, 2023

Meet the Expert: Kamila Rocha

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Press Releases ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

September 27, 2023

ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

September 13, 2023

ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

August 30, 2023

ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 3, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Congratulations to our 2015 Colleague Award Winners!

December 21, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

Press Releases ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

September 27, 2023

ProPharma Appoints Alena Hammond as Global Head of Clinical Operations

Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

September 13, 2023

ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI

Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

August 30, 2023

ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Previous Post Arrow Next Post Arrow
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 03, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Congratulations to our 2015 Colleague Award Winners!

December 20, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Previous Award Arrow Next Award Arrow
FDA Regulatory Sciences The Impact of a US Government Shutdown on the Food and Drug Administration

Sep 27, 2023 11:57:42 AM

The Impact of a US Government Shutdown on the Food and Drug Administration

U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Quality & Compliance Medical Information DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

Sep 25, 2023 4:59:00 PM

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

Meet the Expert Medical Information Meet the Expert: Kamila Rocha

Sep 21, 2023 7:00:00 AM

Meet the Expert: Kamila Rocha

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Infographic Pathways to Market for Medical Devices in the U.S. - ProPharma

September 27, 2023

Pathways to Market for Medical Devices in the U.S.

Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...

Case Study Accelerate European Market Access with Compliant and Comprehensive MAA Submission - ProPharma

October 14, 2021

Accelerate European Market Access with Compliant and Comprehensive MAA Submission

Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

Case Study An Inspection-Ready QMS Accelerates Product Introductions in Europe - ProPharma

February 3, 2022

An Inspection-Ready QMS Accelerates Product Introductions in Europe

Accessing new market is in the European Union can be a challenge especially when having to navigate both specific country and general European regulation. Read how ProPharma Group used their deep...

Case Study Bespoke Regulatory Sciences Teams for Pharmaceutical Companies - ProPharma

November 30, 2021

Bespoke Regulatory Sciences Teams for Pharmaceutical Companies

Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team. ProPharma Group’s team of Regulatory Sciences...

Case Study Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements - ProPharma

March 18, 2022

Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements

There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

Case Study Clinical Monitoring Change Management - ProPharma

October 4, 2021

Clinical Monitoring Change Management

Translating regulatory guidance into success for your organization is difficult when there is not a consistent industry standard. Coupled with new processes and procedures within a company that has a...

Case Study Decentralized Visits in Rare Disease Studies - ProPharma

March 22, 2022

Decentralized Visits in Rare Disease Studies

Learn how ProPharma helped implement and execute decentralized visits for a pediatric rare disease study. The COVID-19 pandemic caused major disruption to many clinical trials and the participants...

Case Study Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area - ProPharma

October 14, 2021

Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area

Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

Case Study Early Phase Oncology Program in Patients with Solid Tumors - ProPharma

September 27, 2023

Early Phase Oncology Program in Patients with Solid Tumors

See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well above industry benchmarks. An emerging Biotech Sponsor needed management and full-service...

Case Study EMA Approval Under Exceptional Circumstances - ProPharma

November 12, 2021

EMA Approval Under Exceptional Circumstances

How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval. You’ve developed a novel drug and obtained FDA approval. Your work is done, right? Not if...

Case Study Ensure Data Integrity Compliance to Prevent Audit Findings - ProPharma

September 27, 2023

Ensure Data Integrity Compliance to Prevent Audit Findings

Ensuring accurate and honest data collection is essential for maintaining the integrity of research. Even though the right mindset is the start of data integrity compliance, that alone is not enough...

Videos Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

September 1, 2022

Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

Videos Insider Talks - Tips From Qualified Persons for Successful Importation - ProPharma

June 27, 2022

Insider Talks - Tips From Qualified Persons for Successful Importation

Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets? You are in the process of obtaining an MA or CTA to bring your product to EEA/UK markets, which can be a complex...

Case Study Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence - ProPharma

October 14, 2021

Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence

Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

Case Study Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons - ProPharma

October 14, 2021

Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons

Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

Case Study EU Medical Device Regulation PMO and Project Delivery  - ProPharma

October 14, 2021

EU Medical Device Regulation PMO and Project Delivery

Regardless of your internal resources, it could be extremely taxing and unrealistic to expect your team to accomplish both their normal daily activities as well as the work necessary to ensure...

Case Study Growing a Culture of Quality and Compliance - ProPharma

November 2, 2021

Growing a Culture of Quality and Compliance

One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or...

Case Study How a Two-Part NDA Regulatory Strategy Resulted in Submission Success - ProPharma

September 27, 2023

How a Two-Part NDA Regulatory Strategy Resulted in Submission Success

Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

Case Study How to Ensure Your Multi-Million Dollar Software Launches on Time - ProPharma

October 14, 2021

How to Ensure Your Multi-Million Dollar Software Launches on Time

Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Implementing a technology solution of this...

Case Study How to Manage a Drug Product in a Medical Device Environment - ProPharma

June 1, 2022

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...

Case Study How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach - ProPharma

October 4, 2021

How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach

A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

Case Study How to Successfully Launch Products with QMS and QP Certification - ProPharma

October 14, 2021

How to Successfully Launch Products with QMS and QP Certification

Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...

Case Study Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline - ProPharma

October 14, 2021

Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline

Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

Case Study Increased Visibility for Senior Management with Custom PMO Design, Implementation - ProPharma

October 4, 2021

Increased Visibility for Senior Management with Custom PMO Design, Implementation

Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

Case Study Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days - ProPharma

October 14, 2021

Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days

In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

Case Study Laboratory Informatics with Robotics - ProPharma

October 4, 2021

Laboratory Informatics with Robotics

Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), instruments, and robotics are immensely complex and...

Case Study Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance - ProPharma

October 14, 2021

Lack of FDA Audit Findings Doesn’t Necessarily Indicate Vendor Compliance

When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their...

Case Study Managing Complex Pharmaceutical Projects - ProPharma

October 4, 2021

Managing Complex Pharmaceutical Projects

There are many obstacles your team may face during product development. One of the hurdles includes project management struggles associated with having too many decision makers. Although it is one...

Case Study MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction - ProPharma

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

Case Study Navigating QMS Requirements from a Medical Device Perspective - ProPharma

April 12, 2022

Navigating QMS Requirements from a Medical Device Perspective

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...

Videos Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life - ProPharma

September 27, 2023

Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life

In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

Case Study Overworked Medical Device Teams Missing Deadlines - ProPharma

October 14, 2021

Overworked Medical Device Teams Missing Deadlines

Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma Group’s team can help. You may recognize that this is happening but not...

Videos Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective - ProPharma

May 19, 2022

Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective

As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

Case Study Program and Project Management Effectively Deliver a QMS Optimization Program - ProPharma

April 25, 2022

Program and Project Management Effectively Deliver a QMS Optimization Program

Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...

Videos Insider Talks - To Decentralize or Not to Decentralize … That is the Question - ProPharma

March 25, 2022

Insider Talks - To Decentralize or Not to Decentralize … That is the Question

Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

Case Study Reduced Burden for Oncology Patients With Decentralized Visits - ProPharma

March 21, 2022

Reduced Burden for Oncology Patients With Decentralized Visits

Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....

Videos AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

February 4, 2022

AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!

Case Study Secure Timely Product Launch by Ensuring GDP Compliance Across Europe - ProPharma

October 14, 2021

Secure Timely Product Launch by Ensuring GDP Compliance Across Europe

Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

Case Study Sponsor Successfully Completes Acquisition After Efficient PMA Submission - ProPharma

July 26, 2022

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how...

Case Study Statistical Analytics with Machine Learning Tool Enablement - ProPharma

October 14, 2021

Statistical Analytics with Machine Learning Tool Enablement

Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...

Videos 20 Years of Improving Patient Health and Safety - ProPharma

January 25, 2022

20 Years of Improving Patient Health and Safety

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Case Study Supporting Decentralized Gene Therapy Visits - ProPharma

February 17, 2022

Supporting Decentralized Gene Therapy Visits

Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study....

Videos Cohort Management Process and Planning: Challenges, Risks, and Mitigations - ProPharma

December 7, 2021

Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.

Videos Expedited Programs Explained: How to Expedite Product Approval in the US and Europe - ProPharma

November 12, 2021

Expedited Programs Explained: How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!

Case Study Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors - ProPharma

October 14, 2021

Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors

Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

Videos What Does it Take to Build a Legacy? (20th Anniversary Video) - ProPharma

October 15, 2021

What Does it Take to Build a Legacy? (20th Anniversary Video)

Case Study Understanding Clinical Trial Requirements for Medical Device Label Extensions - ProPharma

October 14, 2021

Understanding Clinical Trial Requirements for Medical Device Label Extensions

After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

Case Study Using Science to Achieve EMA Approval for a First-in-Class Indication - ProPharma

October 14, 2021

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.

Case Study When a Team Lacks Industry Experience - ProPharma

October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

June 16, 2023

Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC

Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

September 27, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

September 27, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

September 27, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands

June 12, 2023

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Flyers Functional Service Provider (FSP) Value Proposition

June 21, 2023

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Flyers Labeling Development & Intelligence

June 21, 2023

Labeling Development & Intelligence

Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses

June 27, 2023

Enhancing Site Capacity for Clinical Trials with DCT Nurses

Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...

Whitepapers Compliance Auditing: Diving into Common Critical Findings

July 31, 2023

Compliance Auditing: Diving into Common Critical Findings

Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...

Previous Resource Arrow Next Resource Arrow
Gradient Image

Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.