Blog

A post-authorisation safety study is one of the few pharmacovigilance activities where a regulator reviews your methodology before you are allowed to begin. Get the[…]

The environment has become a regulatory obligation for pharmaceutical companies on two fronts at once. On one side sits the marketing authorisation dossier, where the[…]

Antimicrobial resistance is one of the most serious long-term threats to European health systems, yet the pipeline of new antibiotics has thinned to a trickle.[…]

Prefilled syringes, pens, autoinjectors and inhalers are medicines to their manufacturers and patients — but the device that delivers the dose has its own regulatory[…]

EU GMP Annex 11, the rulebook for computerised systems in pharmaceutical manufacturing, dates from 2011 — before cloud computing, software-as-a-service and machine learning were part[…]

The science of obesity treatment has raced ahead of the systems that pay for it. GLP-1 medicines have transformed clinical expectations, but across Europe reimbursement[…]

Artificial intelligence has moved from the margins of drug development into the mainstream of discovery, clinical trials, manufacturing and pharmacovigilance. EU regulators have responded with[…]

Medicine supply security has become one of the most heavily regulated corners of EU pharmaceutical law — and one of the fastest-moving. Between Regulation (EU)[…]

The three ISO standards that matter most in life sciences — and what the 2026 ISO 9001 revision means for companies certified today.

Training is a legal obligation under EU GMP and GDP. What the rules require and how to build a training system that survives inspection.