Operational Excellence in Global Clinical Research: Why Culture Drives Performance
Choosing a CRO Partner: Signals That Matter Most
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...
Regulatory Sciences
ANDA Development Made Clear: Expert Advice on Submission Strategy, Labeling, and Patent Considerations
Inside our Q&A session with former FDA labeling reviewer, Marshall Florence, PharmD., regarding ANDA submission strategy, labeling, and how to effectively use the OrangeBook as a strategic resource....
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...
Regulatory Sciences
FDA's Shift to One Pivotal Trial for Drug Approval: Regulatory Strategy Implications for Sponsors
In a move that could reshape modern drug development, on February 19, 2026, FDA formally confirmed that one adequate and well-controlled pivotal trial may now serve as the default basis for drug...
Quality & Compliance
User Requirements for AI in GxP: Designing, Selecting, and Validating AI/ML Software with Confidence
Artificial Intelligence and Machine Learning are rapidly moving from "innovation pilots" to everyday tools in regulated life sciences organizations, supporting everything from deviation trending and...
Medical Information
Why Medical Information Is Central to MAH Compliance, Access, and Patient Safety – Identifying Reportable Information
Inquirers rarely contact Medical Information (MI) to report an adverse event (AE), special situation event (SSE), or product quality complaint(PQC). They call because they have a question, but...
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...
Quality & Compliance
AI in PV Surveillance: Aligning Innovation with Regulatory Expectations
Artificial Intelligence (AI) is moving quickly from pilot projects into routine pharmacovigilance (PV) operations. The 2025 CIOMS Working Group XIV report on AI in pharmacovigilance provides a...
Regulatory Sciences
Preparing for eCTD 4.0: What FDA Submitters Need to Know
Why Early Planning Matters for Regulatory Operations While it's only been a handful of years since eCTD Version 3.2.2 became the standard submission format for all major components of US regulatory...
Quality & Compliance
Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance
In today's complex life sciences ecosystems, pharmaceutical and biologics companies face unprecedented demands to deliver safe, effective therapies while navigating a global regulatory environment...
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...
Medical Information
Understanding FDA Requirements for Medical Information Services in the US
In the highly regulated industry environment, medical information (MI) services are far more than a support function, providing information to patients, caregivers, and Healthcare Professionals;...
