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.
Quality & Compliance
The FDA's transition from the long-standing Quality System Regulation (QSR, 21 CFR Part 820) to the new Quality Management System Regulation (QMSR) represents one of the most significant regulatory...
Full-Service CRO
Humanized content about engagement strategies with sites and investigators. The Study Start Up (SSU) phase of clinical trials always feels very chaotic when you are in the “thick of it” with...
Regulatory Sciences
In about a week, the committee that advises the FDA on pharmacy compounding will hold a public meeting on several peptides that are popular in sports medicine and do-it-yourself physical...
Regulatory Sciences
The First JCAs Are Revealing More Than a New Process: Early Lessons and JCA Readiness As the first Joint Clinical Assessments (JCAs) moved from planning into practice, a clearer picture is emerging...
Full-Service CRO
Regulatory complexity is unavoidable in global clinical development. The differentiator is not whether organizations face complexity, it is how effectively they operationalize it. Across Europe,...
Full-Service CRO
For years, regulatory readiness was often viewed primarily as a compliance function, an operational necessity required to move clinical studies forward. Today, that perspective is no longer...
Regulatory Sciences
Tech transfers are often treated as operational projects. In reality, the success, and especially the speed, are determined much earlier: by the clarity of your data requirements and gaps, your CMC...
Medical Information
The medical information contact center serves as a critical communication link among clinical studies, healthcare professionals, patients, and caregivers to support clinical or treatment decisions....
Regulatory Sciences
Question & Answer with IVD Expert, Cortez McBerry, PhD The Future of IVDs: How Point-of-Care Testing and Diagnostic Miniaturization Are Transforming Healthcare In vitro diagnostics (IVDs) are rapidly...
Quality & Compliance
ProPharma’s perspective on implementing AI-enabled applications with confidence, compliance, and control Artificial Intelligence (AI) is quickly moving from innovation pilots into core life sciences...
Full-Service CRO
Selecting a contract research organization (CRO) is one of the highest-stakes decisions a sponsor makes during drug or device development. The right partner accelerates timelines, protects data...
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...
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...
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....
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...