global
solutions
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Strategy-Led Solutions on a Global Scale
Our fit-for-purpose global solutions span across the full product lifecycle. 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 & Compliance
RCO - Global Solutions
ProPharma’s team of subject matter experts and skilled strategists is equipped to partner with clients and offers custom solutions for complex needs. ProPharma is changing standardized to strategized across its end-to-end suite of services, with a global reach that ensures success for both existing and prospective clients.
Clinical Research Services
ProPharma offers industry leading support through a global team of trusted experts for multi-phase clinical development and study execution focused on therapies, medical devices, and diagnostics.

Our team of clinical research experts brings breadth and depth of experience across all phases of clinical trials, applying proven techniques to provide innovative solutions. Regardless of where you are in the product lifecycle or what your clinical trial&endash;related needs are, we offer clinical research solutions to efficiently bring your product to market. With decades of industry experience, our team of clinical research experts is current with the latest industry intelligence and ever-evolving regulations, making ProPharma the partner of choice when outsourcing your clinical trials.
Regulatory Operations
ProPharma is the world’s leading regulatory sciences consulting firm offering support across the full life cycle for drugs, biologics, medical devices, and diagnostics. ProPharma offers pre and post approval for FDA, EMA, and national competent authorities.
ProPharma’s aim is to help your business succeed by working to streamline the pharma regulatory process. ProPharma’s experienced regulatory consulting and compliance team commands an unparalleled breadth and depth of knowledge pertaining to the FDA and EMA regulatory frameworks and can work with you to accomplish your business objectives. Our regulatory consultants develop detailed strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We also support post-authorization regulatory pharma needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.
Medical Information
ProPharma provides comprehensive medical information services, including fully integrated 24/7/365 contact centers. Our highly qualified medical information specialists utilize market-leading technologies and innovation to help our clients deliver current and accurate information and improve patient health and safety.
With strategically positioned and seamlessly integrated contact centers around the world, we provide customizable medical information services to meet the needs of companies of all sizes. Whether you need adverse event intake and follow-up, medical writing and content management solutions, promotional review, or other extended medical information services, our team of medical information specialists have the knowledge and experience to effectively support your needs.
Pharmacovigilance
ProPharma is an industry leading organization comprised of pharmacovigilance experts, offering a full suite of pharmacovigilance solutions to ensure safety and consistency from clinical development through post-approval.
ProPharma’s team of highly qualified pharmacovigilance experts, combined with integrated technology, ensures your product meets the highest levels of compliance with both regional and global pharmacovigilance regulations. We are well equipped to expand as your business grows, guiding you through every step of the pharmacovigilance process and pivoting to meet your developing needs. ProPharma’s team is prepared to handle large case volumes at a global scale, supporting clients throughout the complete product lifecycle. Our pharmacovigilance services are available on a standalone basis or can be integrated with global Medical Information and Regulatory Sciences.
Quality & Compliance
ProPharma is an industry leader in quality & compliance with decades of experience in pharma consulting and regulation. ProPharma successfully brings products to market through maintenance of quality and compliance standards and records.
Our team of quality & compliance consultants apply proven and proprietary project management methodologies to help our clients successfully develop and launch products to market. ProPharma offers an expansive suite of consulting services to ensure quality, compliance, efficiency, and safety throughout the full lifecycle of a product. Working as an extension of your team, our consultants support you with the highest quality of services by providing best practices and proven insights on program and process management that are aligned with our mission to improve the health and safety of patients.
Explore Quality & ComplianceNews & Insights

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...

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...

October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 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
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...

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...
News & Insights

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...

October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

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...

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...

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...

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 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...

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...

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 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
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 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...

December 1, 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...

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...

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...

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...

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 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 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 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...

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...
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.