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 ...
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 ...
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 ...
WOODBRIDGE, Conn.--(BUSINESS WIRE)--ChemWerth Inc., a leading supplier of generic Active Pharmaceutical Ingredients (APIs), filed a Drug Master File (DMF) with the Food and Drug Administration (FDA) ...
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 ...
Dublin, Jan. 21, 2025 (GLOBE NEWSWIRE) -- The "Efficient Batch Record Design and Review" training has been added to ResearchAndMarkets.com's offering. This accredited training will identify and ...
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