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 ...

GERMANTOWN, MARYLAND / ACCESS Newswire / March 4, 2025 / uBriGene Biosciences (uBriGene), a leading cell and gene therapy CDMO, is pleased to announce the submission of its Drug Master File (DMF) for ...

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 ...

With the evolution of pharmaceutical industry over the past decades, compliance remains a key factor in bringing novel drugs to market. Proregulations, as a product safety and regulatory consulting ...

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 ...

SEATTLE — Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug ...

FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...

The FDA recently announced the opening of its Radiation Sterilization Master File Pilot Program as the medical device industry wrestles with potential radioactive cobalt supply chain issues and ...