Perspectives on quality, compliance & regulation
Practical guidance from our specialists on the issues shaping pharmaceutical quality and regulatory affairs.
Annex 1 & the Contamination Control Strategy: What Sterile Sites Must Do Now
The revised EU GMP Annex 1 made the Contamination Control Strategy central — and a folder of existing SOPs is not one. How to build a holistic, living CCS that holds up under inspection.
Computer Software Assurance (CSA): Doing Less Validation, Better
CSA and GAMP 5 Second Edition replace documentation volume with risk-based assurance. How to focus validation effort where it actually protects product quality and data integrity.
GMP Compliance Essentials: Building a Quality System That Passes Inspection
What separates sites that breeze through inspections from those that struggle? A practical look at the GMP fundamentals — from data integrity to CAPA effectiveness — that inspectors actually probe.
Surviving an FDA 483 or Warning Letter: A Remediation Playbook
The difference between a site that recovers and one that spirals is decided in the first few weeks. A practical playbook for credible, durable remediation — to demonstrable closure.
AI in Pharmacovigilance: Smarter Signal Detection Without Losing Control
AI-assisted methods can screen vast safety datasets far faster than manual review — but only a disciplined, GVP-aligned process keeps the human judgment regulators expect. Here's how to adopt it responsibly.
eCTD Submissions: Getting It Right the First Time
A well-built eCTD dossier means fewer deficiency letters and a faster approval. We break down the publishing, granularity and validation practices that keep submissions out of the rejection pile.
Nitrosamines and the Modern Impurity Control Strategy
Nitrosamines stress-tested the industry's impurity control discipline. How ICH M7 and Q3 frame a structured, risk-based control strategy — from source mapping to justification.
Choosing a CMO: A Practical Qualification & Technology-Transfer Checklist
CMO partnerships are won or lost before the first batch. A practical checklist for qualifying the CMO and running a technology transfer that preserves process control.
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