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
Europe is one region — but it is far from uniform. For Marketing Authorization Holders (MAHs), providing consistent, compliant Medical Information (MI) support across the continent requires...
Quality & Compliance
As global regulatory expectations evolve, one trend is unmistakably clear: Marketing Authorization Holders (MAHs) must take a more proactive role in monitoring and managing supplier compliance....
Regulatory Sciences
For decades, FDA's Investigational New Drug (IND) application has been viewed primarily as a regulatory gateway. Submit the application, obtain FDA's approval to proceed, and begin clinical trials....
Medical Information
In the highly regulated pharmaceutical industry, maintaining a robust pharmacovigilance system is essential to ensure patient safety and regulatory compliance. One of the most critical documents...
Medical Information
For Marketing Authorization Holders (MAHs), ensuring that healthcare professionals (HCPs) and patients can easily access the organization is essential to delivering safe, compliant, and high‑quality...
FSP Solutions
In today's fast-paced clinical research environment, pharmaceutical and biotech companies face mounting pressure to deliver high-quality documentation under tight timelines. Medical writing is a...
Quality & Compliance
Choosing a CRO Partner: Signals That Matter Most Operational excellence is often discussed as a performance outcome. Hit timelines. Stay on budget. Improve cycle times. Reduce deviations. Those...
Regulatory Sciences
In today's evolving regulatory and legal landscape, few issues are as consequential for generic drug development as the use of so-called "skinny labels." The recent decision by the U.S. Supreme Court...
Full-Service CRO
Clinical research sites are carrying more responsibility than ever before. Staffing shortages, increasing protocol complexity, administrative burden and growing regulatory expectations place heavy...
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...
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...
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...
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...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
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...