AI-Readiness 101: AI Success Starts with Understanding Your Data
Everyone wants AI.
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;...
Quality & Compliance
Annex 11 2011 Version vs. Annex 11 2025 Draft Version: What are the Differences and Enhancements?
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and...
Pharmacovigilance
Rescuing a Struggling PV Program: Warning Signs, Root Causes, and What to Do Next
Living near the ocean growing up, I have been warned countless times that by the time you realize you are in a riptide, you may already need to be rescued. You'll know things aren't going quite...
Quality & Compliance
Good Machine Learning Practice (GMLP)
Artificial Intelligence (AI) and Machine Learning (ML) technologies are transforming the life sciences landscape, driving innovation across drug discovery, clinical research, manufacturing, and...
Regulatory Sciences
Influencers in Pharma: A Growing Compliance Frontier
As digital marketing evolves, prescription drug promotion is expanding into spaces traditionally dominated by consumer brands. Pharmaceutical companies are increasingly collaborating with...
Regulatory Sciences
Reclaiming the European Market: How to Secure EU/UK MAH Status Without the Local Infrastructure
For many US and APAC pharmaceutical companies, reacquiring the European rights to a successful, out-licensed product is a smart strategic move — an opportunity to capture greater margins, regain...
Regulatory Sciences
FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications
On Tuesday, September 9, 2025, the Department of Health and Human Services (HHS) and FDA both issued press releases and a fact sheet launching a crackdown on deceptive drug advertising. In the FDA's...
