First Joint Clinical Assessments (JCAs): Key Lessons for EU HTA
The First JCAs Are Revealing More Than a New Process: Early Lessons and JCA Readiness
Clinical Research Solutions
Turning Regulatory Complexity into Predictable Study Start-Up Execution
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,...
Clinical Research Solutions
Regulatory Readiness as a Strategic Advantage in European Study Start-Up
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
Successful Tech Transfers Require Both Strong Regulatory Strategy and Execution
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
Responsible AI in Medical Information: Safety, Ownership, Oversight
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
FAQ: In Vitro Diagnostics (IVDs)
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
A Risk-Based Road Map for Implementing AI
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...
Clinical Research Solutions
Five Metrics That Predict CRO Success (and How to Measure Them)
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
FDA Adds Bemotrizinol to OTC Sunscreen Monograph: What the New GRASE Determination Means for Manufacturers
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
Modernizing Case Management for Global Compliance
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
Accelerating European Market Entry: The Strategic Advantage of Using FDA Approval in the UK’s IRP
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
Why Medical Information Is Critical to Adverse Event Reporting
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
Rethinking the Role of the Medical Information Contact Center: An Untapped Resource for Medical Writing
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 Resourcing in Modern Clinical Trials
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
The Hidden Value of Medical Information: Strengthening Brand Trust
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
Understanding For-Cause Audits: A GMP Case Study
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;...
