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 ...
SALT LAKE CITY, UT--(Marketwired - Sep 13, 2016) - MasterControl (RAPS booth #301), a leading global provider of enterprise quality management systems (EQMS) and quality consulting services, will ...
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) ...
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 ...
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 ...
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 ...
Albumedix Ltd. (‘Albumedix’), the world leader in recombinant human albumin (rHA), announced today that the Center for Biologics Evaluation and Research (CBER), one of six main centers for the U.S.
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs. The authors present analysis of the state of control of ...
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