Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in CNS drug and device development, today announced it has successfully completed an inspection by ...

We are very proud of this result. A no‑483 outcome is a testament to the discipline, expertise, and dedication of our ...

Mumbai: Regulatory clearances remain a key milestone for pharma companies, and Piramal Pharma’s latest update signals steady compliance progress in its US operations.

Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...