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
Regulatory Sciences
Cyberattacks in MedTech: Lessons from Stryker, Intuitive, & FDA's Cybersecurity Expectations
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
The Strategic Importance of a Consumer Health Service Line
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
When AI Meets CGMP: Lessons from FDA's First Warning Letter on Non-Compliant AI Use in Manufacturing
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
Offshoring Medical Information Services: A Breakthrough Trend to Achieve 24/7 Global Market Reach
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
Preparing for EMA Policy 0070: How to Stay Ahead of the Anonymization Curve
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
Navigating Medical Inquiries Across Europe: Why Multilingual Support Matters for MAHs
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
From Reactive to Proactive: The New MAH Compliance Standard
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
The IND is More Than Just an FDA Submission: It’s a Regulatory Positioning Strategy
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
Mastering the Pharmacovigilance System Master File (PSMF): A Guide to Inspection Readiness
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
A Smarter Front‑Desk Model: Multilingual Contact Center Support for MAHs
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
The Evolving Role of Functional Service Providers in Clinical Trial Medical Writing: Efficiency, Compliance, and Collaboration
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
Operational Excellence in Global Clinical Research: Why Culture Drives Performance
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
Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Developers
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...
Clinical Research Solutions
Benefits of Site Support
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
Global Medical Information, Local Voices: Multilingual Contact Centers That Scale
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...
