RCO solutions
Our fit-for purpose global solutions span across the full product lifecycle.
The World's Largest RCO
ProPharma offers a suite of fully customizable consulting solutions across service lines and functional areas of expertise. We collaborate with clients to co-create optimal solutions, build sustainable and scalable operating models, operationalize robust execution, and position our clients for development and growth.
Product Lifecycle
Domain Expertise
Select from a comprehensive array of full product lifecycle services to create a fit-for-purpose solution. These services by design, operate autonomously in a model that can be engaged individually to help with a specific need or assembled into an integrated end-to-end construct that can flex up or down in scope/scale as programs evolve. Our deep domain expertise helps you solve your most complex research problems across the following areas:
- Strategic Consulting
- R&D Information Technologies
- Biostatistics & Data Science
- Regulatory Sciences
- Rare Disease & Orphan R&D
- Cell & Gene Therapy
- Peri/Post-Approval
Global Solutions
Our fit-for-purpose global solutions span across the full product life cycle with a team of experts who bring a comprehensive portfolio of services to help solve complex challenges in a dynamic environment. ProPharma’s global expertise includes:
- Clinical Research Services
- Regulatory Operations
- Medical Information
- Pharmacovigilance
- Quality and Compliance
The Future of Research Consulting is Here
We’ve revolutionized the traditional model and put our clients at the very center. Our new system delivers better solutions and completely redefines what’s possible for you and your organization.
Client Feedback
"The ProPharma Group has been a valued and trusted partner as our Medical Information third party call center for a number of years. During that time they have exhibited the highest level of quality, compliance, and professionalism. Always keeping the needs of our mutual customers front and center. The team is diverse in their staff and their offered services, which enables us to customize support to business need. We would highly recommend the services of ProPharma without hesitation.”
Laurie Wingett - Bayer, Inc.
Medical Affairs Head, Primary Care (WH/established brands) and Medical Operations
“Working with ProPharma has been a pleasure. The auditors are friendly, knowledgeable, and communicative. They have been a great resource to help us complete a wide range of audits and
manage our supplier quality.”
Emily King - Azurity Pharmaceuticals
"Working with the whole team at ProPharma Group has been an honor. For several years they have acted on our behalf as a trusted customer facing vendor for medical information inquiries. their subject matter expertise, collaborative nature and high level of professionalism have been a bellwether for us through all stages of marketing and scaling a new drug product. The next time my team is in need of scientific communication outsourcing, PPG will be my first stop."
Jenny Strauss - Biohaven Pharmaceuticals
Manager, Medical Information and Communications
“Lyell engaged ProPharma as our validation partner as we built and qualified the LyFE Manufacturing Center. ProPharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”
David Shank - Lyell Immunopharma, Inc.
Vice President, Manufacturing
When we partnered with Oxford University to enable global development, manufacturing and distribution of our vaccine, we put broad and equitable access at the heart of our response. The result was a vaccine that was developed in under a year, and we believe we have made a significant impact in terms of global public health. Based on data published in The Lancet and an analysis by Airfinity, our vaccine is estimated to have saved over 6 million lives in the first year of vaccination.
AstraZeneca supplied the vaccine with no profit during the pandemic and we are supplying the vaccine with no profit in low-income countries today. To date, over 3 billion doses have been released for supply to more than 180 countries. AstraZeneca was the first and largest contributor in 2020 and 2021 to COVAX, with over 470 million doses. Doses that couldn’t have been released without the partnership with ProPharma. In our collaboration an estimated 500 million doses underwent thorough quality assessment to provide a vaccine made for the world.
Pythia Segers - Astra Zeneca
"We have had the pleasure of working with ProPharma on a global scale for several years assisting us with Medical Information Call Center and writing workflows. Their ability to adapt based on the client’s needs is very commendable. Also, we are fortunate to work with a very talented team of professionals who are always eager to work with us and deliver quality service to our customers."
Anonymous
News & Insights
December 6, 2023
Meet the Expert: Clarence Young
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...
November 27, 2023
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
November 20, 2023
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
December 6, 2023
ProPharma Expands into Central and Eastern Europe Through Acquisition of Clinres Farmacija
RALEIGH, NC, December 6, 2023 – ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and compliance services...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
November 16, 2023
ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...
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...
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...
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...
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...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
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
December 06, 2023
ProPharma Expands into Central and Eastern Europe Through Acquisition of Clinres Farmacija
RALEIGH, NC, December 6, 2023 – ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and compliance services...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
November 16, 2023
ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...
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...
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...
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...
Dec 6, 2023 4:06:16 PM
Meet the Expert: Clarence Young
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...
Nov 27, 2023 7:00:00 AM
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
Nov 20, 2023 7:00:00 AM
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
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...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
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...
December 7, 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...
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...
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 used their deep...
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’s team of Regulatory Sciences experts...
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...
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...
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...
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...
December 7, 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...
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...
December 7, 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...
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...
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...
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...
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...
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...
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...
December 7, 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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
December 7, 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...
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’s team can help. You may recognize that this is happening but not necessarily know...
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...
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...
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...
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....
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!
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...
July 26, 2022
Sponsor Successfully Completes Acquisition After Efficient PMA Submission
A major Top 10 Medical Device Sponsor engaged M2, a ProPharma company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how 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...
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.
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....
December 7, 2021
Cohort Management Process and Planning: Challenges, Risks, and Mitigations
Learn novel and useful drug design methodologies based on ProPharma's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.
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!
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...
October 15, 2021
What Does it Take to Build a Legacy? (20th Anniversary Video)
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...
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...
October 13, 2021
The True Cost of Non-Compliance
How to avoid getting your first, second, and third warning letter from a federal agency.
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...
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...
October 4, 2021
ProPharma 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.
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...
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...
December 7, 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...
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.
October 14, 2021
EMA Services: Ensure Regulatory Success
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
December 7, 2023
Accelerating Your Product Through Drug Development
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
October 14, 2021
Cell and Gene Therapy Center of Excellence
Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients
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
October 14, 2021
FDA Consulting: Regulatory Strategy Expertise
Reduce Your Time to Market With an Effective FDA Regulatory Strategy
October 4, 2021
ProPharma Services Overview
Improving Patient Health and Safety. At Every Step.
October 4, 2021
Medical Device Development
Navigate Complex Global Requirements for Medical Device Approval
October 4, 2021
EU Market Access: Accelerate Market Access to Europe with MIA License
Reduce Launch Timeline and Improve Business Efficiency
December 7, 2023
Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)
Save Time and Boost your Bottom Line
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...
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...
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...
October 14, 2021
A Guide for Efficacious Data Integrity During COVID-19
Learn how ProPharma implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains, and...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
October 16, 2023
Biostatistics and Programming - More than Just Clinical Trials
Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.
October 19, 2023
Product Quality Complaint Management
Ensuring the safety and health of patients is of utmost significance when it comes to pharmaceuticals, medical devices, and diagnostic programs. This is especially vital in today's intricate and...
November 6, 2023
Tackling Product Quality and Safety Issues through Global Collaboration
See how ProPharma effectively addressed a globally renowned corporation's surge in product quality complaints and financial pressures by establishing a tiered support system, leveraging offshore...