Inspiring the future of science to
deliver the technologies, medicines
& therapies of tomorrow.
We're pleased to announce that ProPharma has secured its position on the Inc. 5000 List of America's Fastest-Growing Companies for 2023, ranking at 1,678.
Aligning with World Health Day, ProPharma has released a short documentary video demonstrating the value of our unique RCO model which strives to improve global health outcomes.
Watch the Video →
The traditional CRO model wasn’t built to handle today’s needs. As the first ever Research Consulting Organization (RCO), we lead with strategy; this enables customized design and delivery of consulting solutions that are equipped to successfully navigate the increasingly complex global Regulatory environment.
Our scalable nature and agility allows each part of our business to invest, innovate, and continuously improve to provide the right solutions for our clients.
- Michael Stomberg, Chief Executive Officer
We revolutionized the traditional model, creating an entirely new system that redefines what’s possible for you and your organization. Meet the Research Consulting Organization (RCO).
One size has never fit all. We’re here to offer a custom alternative that fits your unique needs. A+ solutions scaled to your size. Each of our dedicated service lines provides world-class critical consulting services that operate autonomously across regulatory, safety, technology, and operations, but can perform as an integrated whole.
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Our team of experts have decades of experience across a wide variety of therapeutic areas & specialties. We work as an extension of your team, bringing you immediate resources who will align with your needs, processes, and environment.
September 29, 2023
As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...
September 27, 2023
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...
September 25, 2023
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...
September 27, 2023
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...
September 13, 2023
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...
August 30, 2023
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...
May 3, 2022
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 is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...
December 21, 2015
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
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
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...
October 4, 2021
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...
September 27, 2023
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...
September 13, 2023
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...
August 30, 2023
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...
May 03, 2022
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 is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...
December 20, 2015
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...
Sep 29, 2023 7:00:00 AM
As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...
Sep 27, 2023 11:57:42 AM
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...
Sep 25, 2023 4:59:00 PM
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...
June 10, 2022
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
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...
October 4, 2021
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...
October 1, 2023
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
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
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...
November 30, 2021
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...
March 18, 2022
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
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
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
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...
October 1, 2023
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
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...
October 1, 2023
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
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
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 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
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
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
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...
October 1, 2023
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
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
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
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
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
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
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
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
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
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
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
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
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...
October 1, 2023
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
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...
May 19, 2022
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
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
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
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 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
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
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...
October 14, 2021
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
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
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
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.
November 12, 2021
Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!
October 14, 2021
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
October 14, 2021
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
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
How to avoid getting your first, second, and third warning letter from a federal agency.
October 14, 2021
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
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
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
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
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...
October 1, 2023
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
The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.
October 14, 2021
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
October 1, 2023
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
October 14, 2021
Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients
October 14, 2021
Regulatory Agencies Expect Controls to Be in Place
October 14, 2021
Reduce Your Time to Market With an Effective FDA Regulatory Strategy
October 4, 2021
Improving Patient Health and Safety. At Every Step.
October 4, 2021
Navigate Complex Global Requirements for Medical Device Approval
October 4, 2021
Reduce Launch Timeline and Improve Business Efficiency
October 1, 2023
Save Time and Boost your Bottom Line
October 17, 2021
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
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
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
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,...
October 14, 2021
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
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 (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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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 Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...
Our team has a consistent pulse on industry changes, the evolving marketplace, and patient needs. We are excited to attend several events in 2023. We look forward to meeting you to share new insights, explore new perspectives, uncover unmet business needs, and continuing professional development.
October 4, 2023 - October 5, 2023
Empowering patients, physicians, drug manufacturers & consumers to make the best drug safety decisions The World Drug Safety Congress Europe will bring together drug safety, pharmacovigilance, data analytics, epidemiology, and other key players in the biopharma sector. Explore the use of big data and AI in pharmacovigilance, examine benefit-risk management strategies and patient-centric...
We’ve revolutionized the traditional model and put our clients at the very center.