Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Mar 4, 20231 min read

Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products

Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...

Mar 1, 20231 min read

USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens

Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...

Mar 1, 20231 min read

ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products

In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...