A description of the various stages and sections of a Master Regulatory File (MRF) System. As an investigational product progresses through development key studies, decisions, regulatory ...

Deerfield, Illinois, Feb. 27, 2025 (GLOBE NEWSWIRE) -- DEERFIELD, IL. February 27, 2025 – Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on ...

LINCOLN, Neb.--(BUSINESS WIRE)--LI-COR Biosciences announces an Active Substance Master File (ASMF) for IRDye 800CW N-succidimidyl ester is on record with European regulatory authorities in support of ...

HAMPTON, England--(BUSINESS WIRE)--Touchlight, a biotechnology company pioneering enzymatic DNA production to enable genetic medicines, today announced a ground-breaking new milestone for its ...

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained ...

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 ...

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions. Drug Master File (DMF) holders provide a hazard assessment for impurity classification to comply with ...

In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract ...

Dublin, July 18, 2025 (GLOBE NEWSWIRE) -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance - Online Training (August 20, 2025)" has been added to ResearchAndMarkets.com's ...