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.
Regulatory Sciences
On June 10, 2026, FDA issued a final administrative order (OTC000039) amending the OTC monograph for sunscreen drug products to include bemotrizinol as a generally recognized as safe and effective...
Medical Information
One of the biggest challenges in pharmacovigilance is knowing (and staying informed of) regional and country requirements for adverse event reporting. There are so many different requirements,...
Regulatory Sciences
The UK’s Evolving Role in Global Regulatory Strategy Since Brexit, the United Kingdom has continued to reshape its regulatory framework with a strong emphasis on innovation, agility, and accelerated...
Medical Information
Adverse event (AE) reporting is one of the most critical responsibilities across the pharmaceutical industry. At its core, pharmacovigilance (PV) exists to protect patient safety and maintain...
Medical Information
In many organizations, teams are being asked to deliver greater value with limited resources. This has prompted a closer look at existing functions to identify where capabilities may be...
Quality & Compliance
Rethinking biometrics as a strategic function to improve consistency, scalability, and clinical trial performance. Biometrics has become one of the most critical components of clinical development....
Medical Information
Pharmaceutical companies are not always portrayed positively in the media or fully appreciated by customers. A common perception persists that the industry prioritizes revenue over patient...
Quality & Compliance
Opening Scene: A Routine Batch Review, Or So It Seemed It started, as many GMP investigations do, with a routine batch review. But this time, the review wasn't happening on the manufacturing floor;...
Regulatory Sciences
Why Sponsors Should Pressure-Test Their IND Before Submission For many sponsors, the Investigational New Drug (IND) application is viewed as a procedural milestone, the point at which a development...
Regulatory Sciences
Cybersecurity threats are no longer theoretical risks for medical device manufacturers. They are operational, regulatory, and patient safety events unfolding in real time. Recent cybersecurity...
Medical Information
In today's rapidly evolving healthcare landscape, Consumer Health brands face growing expectations to provide timely, accurate, and accessible support directly to their consumers. From nutritional...
Quality & Compliance
The FDA's April 2026 Warning Letter to Purolea Cosmetics Lab is a notable milestone for the pharmaceutical industry. While there have been prior Warning Letters involving products that incorporate...
Medical Information
As the healthcare and pharmaceutical industries continue to grow globally, many companies are increasingly leaning into offshoring medical information services. Medical information teams play a...
FSP Solutions
Under Policy 0070 from the European Medicines Agency (EMA), sponsors are required to submit anonymized clinical reports for publication on the Clinical Data Publication (CDP) portal. Once published,...
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...
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’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....
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...
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...
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...