Quality & Compliance
QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Regulation
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...
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...
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....
Regulatory Sciences
IND Readiness Isn't a Checkbox Exercise, It's a Regulatory Risk Management Strategy
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...
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,...
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....
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...
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...
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...
Regulatory Sciences
Marketing Authorization and Market Access: Navigating Pricing & Reimbursement Before and After Approval in Europe
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
Clinical (IMP) Drug Supply…It's Complicated
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...
Medical Information
Why Clients Are Centralizing Medical Information Functions
Why Consistency in Medical Information Matters A doctor in Germany and a doctor in Canada ask the same question about the safety and effectiveness of a medication. They should receive the same...
Regulatory Sciences
2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026
2025 was a year of significant regulatory disruption. One that will have lasting implications for how pharmaceutical companies approach advertising and promotion in 2026. From an unprecedented surge...