Insights & News
Discover more about ProPharma and how its dedicated team of industry-leading experts supports clients at every step through the product lifecycle.
Thought Leadership
ProPharma’s team of dedicated experts provides strategic guidance across the entire product lifecycle, helping pharmaceutical, biotechnology, and medical device companies navigate complex challenges with confidence. By leveraging deep industry expertise and data-driven insights, we deliver tailored solutions that support regulatory compliance, clinical development, and patient safety.
ANDA Development Made Clear: Expert Advice on Submission Strategy, Labeling, and Patent Considerations
Inside our Q&A session with former FDA labeling reviewer, Marshall Florence, PharmD., regarding ANDA submission strategy, labeling, and how to effectively use the OrangeBook as a strategic resource. Laying the Groundwork for ANDA Success: The Role of the 505(j) Pathway and Reference Products...
Marketing Authorization and Market Access: Navigating Pricing & Reimbursement Before and After Approval in Europe
For decades, pricing and reimbursement activities have been handled separately from the regulatory process and typically only began once regulatory approval was secured. This separation has largely been driving the heterogeneity of pricing and reimbursement decisions and policies across nations in...
FDA's Shift to One Pivotal Trial for Drug Approval: Regulatory Strategy Implications for Sponsors
In a move that could reshape modern drug development, on February 19, 2026, FDA formally confirmed that one adequate and well-controlled pivotal trial may now serve as the default basis for drug approval, rather than the long-standing expectation of two. The announcement and all accompanying...
Resources
ProPharma is committed to delivering dynamic research and perspectives crafted by world-class subject matter experts. ProPharma provides valuable insights to its clients to enable thoughtful decision making, as well as informed resource & investment allocation.
Setting up a Global PV System
A company needed to rapidly establish a fully compliant global pharmacovigilance (PV) system, including UK/EU QPPV coverage, to meet regulatory requirements by a fixed deadline. With safety data and license responsibilities held by a licensing partner, the transition posed significant regulatory,...
High-Volume Global Pharmacovigilance Onboarding
A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding timelines, and the challenge of training large, distributed teams placed data quality, compliance,...
Stabilizing High-Volume Legal Case Processing Through Structured Governance
ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of patient medical records increased exposure to compliance gaps, duplicate cases, and compromised data...
Press Room
ProPharma is at the forefront of the life sciences industry and continues to innovate and elevate its position as a pharmaceutical and MedTech service provider. Stay up to date on ProPharma's latest news and most recent announcements.
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets
Life Sciences Consulting Leader Validates Science-Based Climate Commitments, Reducing Emissions Across Its Global Operations Raleigh, NC, January 27, 2026 – ProPharma, a leading provider of regulatory, clinical, and compliance services for the life sciences industry, announced today that its...
ProPharma Expands Operations with New Office in Hyderabad
Modern workspace supports continued growth and innovation RALEIGH, December 11, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced the official...
ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions
Strategic Structural Update Positions ProPharma As Market Leader RALEIGH, December 4, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced that it has...
Awards
With over 20 years of proven success, ProPharma continues to be acknowledged within the life sciences industry for providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma proudly shares its recognition and achievements as its team works to improve the health and safety of patients.
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets
Life Sciences Consulting Leader Validates Science-Based Climate Commitments, Reducing Emissions Across Its Global Operations Raleigh, NC, January 27, 2026 – ProPharma, a leading provider of regulatory, clinical, and compliance services for the life sciences industry, announced today that its...
ProPharma Expands Operations with New Office in Hyderabad
Modern workspace supports continued growth and innovation RALEIGH, December 11, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced the official...
ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions
Strategic Structural Update Positions ProPharma As Market Leader RALEIGH, December 4, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced that it has...
Events
ProPharma is committed to engaging with both existing and prospective clients at the right time and in the right place. Speak with a member of the team at one of these upcoming events.
Overcoming Challenges. Advancing Patient Care.
Bringing new therapies to market is more complex than ever. ProPharma helps you navigate regulatory challenges with expert guidance, ensuring compliance and accelerating patient access to life-changing treatments.