ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Medical Information
In today's global pharmaceutical landscape, Medical Information (MI) teams must deliver timely, accurate, and compliant scientific responses across borders, time zones, and languages. Healthcare...
Regulatory Sciences
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....
Regulatory Sciences
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...
Quality & Compliance
Things to consider and how to ease the process IMP Supply Management is a journey where GMP, GCP, and GDP meet. This journey includes finance, flow of products, and documentation. How a company...
Regulatory Sciences
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...
Quality & Compliance
Artificial Intelligence and Machine Learning are rapidly moving from "innovation pilots" to everyday tools in regulated life sciences organizations, supporting everything from deviation trending and...
Medical Information
Inquirers rarely contact Medical Information (MI) to report an adverse event (AE), special situation event (SSE), or product quality complaint(PQC). They call because they have a question, but...
Medical Information
Why Consistency in Medical Information Matters A doctor in Germany and a doctor in Canada ask the same question about the safety and effectiveness of a medication. They should receive the same...
Quality & Compliance
Artificial Intelligence (AI) is moving quickly from pilot projects into routine pharmacovigilance (PV) operations. The 2025 CIOMS Working Group XIV report on AI in pharmacovigilance provides a...
Regulatory Sciences
Why Early Planning Matters for Regulatory Operations While it's only been a handful of years since eCTD Version 3.2.2 became the standard submission format for all major components of US regulatory...
Quality & Compliance
In today's complex life sciences ecosystems, pharmaceutical and biologics companies face unprecedented demands to deliver safe, effective therapies while navigating a global regulatory environment...
Regulatory Sciences
2025 was a year of significant regulatory disruption. One that will have lasting implications for how pharmaceutical companies approach advertising and promotion in 2026. From an unprecedented surge...
Medical Information
In the highly regulated industry environment, medical information (MI) services are far more than a support function, providing information to patients, caregivers, and Healthcare Professionals;...
Quality & Compliance
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and...
Pharmacovigilance
Living near the ocean growing up, I have been warned countless times that by the time you realize you are in a riptide, you may already need to be rescued. You'll know things aren't going quite...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...