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

discovery & development

Drug discovery specialists for all phases of your product lifecycle.

Discovery and Development_Mobile Subhero Image-1

Accelerate Drug Development

Delivering new drugs and therapies to market is a complex process which includes both discovery (target identification and validation, hit identification, lead generation & optimization, identification of a viable candidate for future & further development) and development (optimization of chemical synthesis and formulation, toxicological studies, clinical trials, and regulatory approval) stages. ProPharma’s expertise spans across the following Discovery and Development competencies:

  • Technology Transformation
  • Research Platforms
  • Target Identification
  • Lead Validation
  • Scientific Advisory and Regulatory
Colorized half circle.

Discovery & Development Services

ProPharma’s Discovery and Development experienced consulting services help you avoid potential obstacles, navigate the drug development process and expedite your efforts to ensure the best possible outcome for your assets.

Technology Transformation

Now, more than ever, companies are transferring products and processes from one site to another, often facing limitations on time, resources, and regulatory expectations. Transfers can be complicated, and many companies don’t have a technology transfer plan, standard operating procedures (SOPs) or guidelines in place to effectively conduct the transfer.

Our cross-functional team of consultants have proven success in managing product and process transfers for clients around the world.

Manageable Milestones for Successful Technology Transfers

Milestones for Technology Transfer

 

ProPharma’s proprietary Gated Technology Transfer disciplines are customizable to meet your specific production and technology demands.

Our approach provides a robust process framework to consistently transfer technologies from development to production, or from site to site in a compliant and efficient manner.

We collaborate with you to finalize the milestones (or gates) so that your organization understands the approach and can effectively make decisions throughout the process. We have successfully completed more than 175 product transfers using our Gated Technology Transfer approach. Clients credit this successful methodology in helping them navigate the complexities of the technology transfer process while realizing efficiencies along the way. 

Talk to an Expert

Research Platforms

ProPharma understands that you have an important job in getting your product to the clinic and eventually to patients. Your technology should enable you to do this more quickly and efficiently. Let our team of experts develop and deliver tailored roadmaps to help you hit your milestones.

Key Platforms

There is a range of Research systems that can store your data and provide analytics to help you make data-driven decisions about the outcomes of your study. These systems support the life cycle of your product and are comprised of an array of technologies including:

  • Electronic Lab Notebooks (ELNs)
  • Research Data/Laboratory Data Management Systems (LIMS)
  • Document Management Systems
  • Imaging Platforms
  • Data Warehouse and Analytics
  • Data Visualization and Reporting
  • Bioinformatics & Data Science platforms
  • Machine Learning/Artificial Intelligence Platforms (ML/AI)


Talk to an Expert

Target & Lead Selection

Propharma’s team of leading regulatory experts utilize a science-first approach to understanding your product, combined with first-hand insights of regulatory expectations to augment target-to-disease relation. Expert review of the literature, in vitro, ex vivo, in silico, and early non-Good Laboratory Practice (GLP) exploratory in vivo assessments will enable the selection of drug candidates with an acceptable safety profile and provide the opportunity to reduce attrition and increase the success of drug development.

Expert Discovery/Exploratory Toxicology Assistance

ProPharma’s experts understand regulators’ interest in biomarker and mechanistic data and the ability of these data to define organs’ and cells’ sensitivity to therapeutic agents. We can assist with the design, evaluation, and optimization of investigative toxicity and exploratory/discovery studies for candidate therapeutics early in the drug discovery process. In addition to a Sponsor’s own data, we utilize publicly available information to identify potentially supportive data.

ProPharma can help establish the relevance of in vitro and animal data to humans in support of the initiation of clinical testing. Our expertise in typical early discovery assessments includes, but is not limited to:

  • In vitro and in vivo models for the mechanism of action and efficacy assessments
  • CEREP/Kinase panels to flag off-target activities of compounds
  • Cell culture, tissue slice, 3D tissues models, and Organs on a Chip
  • In vitro human ether-a-go-go-related gene (hERG) and cardiovascular studies
  • In vivo cardiovascular, pulmonary, central nervous system (CNS), gastrointestinal, and renal assessments
  • In vitro metabolism and drug interaction studies
  • In vivo pharmacokinetic (PK) studies (various species and routes of administration)
  • Quantitative structure-activity relationship (QSAR) assessments for genotoxic potential
  • In vitro and in vivo genotoxicity tests

Talk to an Expert

Toxicology

 

Scientific Advisory and Regulatory

ProPharma provides high-value advisory services through its worldwide base of top-tier expert consultants, who support the full product development life cycle, from initial concept to marketing authorization. Advisory services include product development and regulatory strategy, development program planning and management, and expert scientific and technical advice.

 

Expert Advisory Services

 

Expert Advisory Services

ProPharma’s worldwide team is comprised of highly knowledgeable experts with extensive experience preparing and submitting applications, including:

  • Investigational New Drug (IND) applications
  • Abbreviated New Drug Applications (ANDAs)
  • New Drug Applications (NDAs)
  • Biologics License Applications (BLAs)
  • Premarket Approval (PMAs)
  • 510(k) (Premarket Notification) and de novo submissions
  • Special designations

ProPharma’s team of experts can act as the Regulatory Representative for the FDA and international regulatory bodies on behalf of a client and can take on leadership roles such as membership on Scientific Advisory Boards or working on a part-time basis as an interim executive (e.g., Chief Medical Officer, Head of CMC, and Head of Regulatory Affairs).


Talk to an Expert

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.

News & Insights

Program & Project Management Drug Development Key Challenges of Specialty Pharma Drug Development Project Management

May 29, 2023

Key Challenges of Specialty Pharma Drug Development Project Management

Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

Meet the Expert Meet the Expert: Collin Freeman

May 25, 2023

Meet the Expert: Collin Freeman

  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...

Meet the Expert Meet the Expert: Tiffany Rice

May 18, 2023

Meet the Expert: Tiffany Rice

    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 Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

May 17, 2023

ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Press Releases ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

May 9, 2023

ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

Press Releases EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

May 1, 2023

EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are building bolder futures   RALEIGH, NC, May 1, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

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 Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

May 17, 2023

ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Press Releases ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

May 09, 2023

ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

Press Releases EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

May 01, 2023

EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are building bolder futures   RALEIGH, NC, May 1, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

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
Program & Project Management Drug Development Key Challenges of Specialty Pharma Drug Development Project Management

May 29, 2023 7:00:00 AM

Key Challenges of Specialty Pharma Drug Development Project Management

Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

Meet the Expert Meet the Expert: Collin Freeman

May 25, 2023 7:00:00 AM

Meet the Expert: Collin Freeman

  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...

Meet the Expert Meet the Expert: Tiffany Rice

May 18, 2023 7:00:00 AM

Meet the Expert: Tiffany Rice

    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

May 30, 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

May 30, 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

May 30, 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

May 30, 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 Group 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...

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

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

May 30, 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.  

Flyers QP MIA Survey - Progress Self-Assessment - ProPharma

August 8, 2022

QP MIA Survey - Progress Self-Assessment

Use this readiness questionnaire to assess the current state of your progress.

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

May 30, 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

May 30, 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)

May 30, 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...

Previous Resource Arrow Next Resource Arrow