Ever present but seldom seen, while being increasingly vital, the rapidly expanding area of the Chemistry, Manufacturing and Controls (CMC) of pharmaceutical products is gradually developing into a ...

Broadly written guidelines raise so many half-truths and misconceptions and are subject to interpretation, so at any given phase of clinical development it is hard to know with any certainty what ...

Dr. Srinivasan provides 30 years of broad regulatory and drug development experience including a career serving as Director of CMC Regulatory Affairs for Regeneron Pharmaceuticals, Inc. where he led ...

BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics today announced the addition of two senior leaders who bring substantial experience guiding regulatory strategy and managing clinical development ...

The Certificate in Regulatory Affairs for Cell and Gene Therapy trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students will learn how to manage ...

Regulatory affairs professionals are meticulous, strive for perfection, and have a strong sense of ethics and interest in regulations. Regulatory affairs professionals ensure that new drugs and ...

Dompé farmaceutici is an international biopharmaceutical company involved in all activities of the pharmaceutical value chain, from research to development, production and marketing. For our office in ...

CLEVELAND--(BUSINESS WIRE)--The Ohio Clinical Trials Collaborative (OCTC) and Bryla CMC-Reg Consulting, LLC, of Snohomish, Wash., have entered into a co-marketing agreement to leverage the synergies ...

Dr. Lopa Bakrania has 18 years of pharmaceutical process chemistry and CMC regulatory affairs experience. She is the Executive Director and Head of CMC Regulatory Affairs at Biohaven. Prior to ...

Markets Insider and Business Insider Editorial Teams were not involved in the creation of this post. Cytodyn NewsMORE Related Stocks Indices Commodities Currencies Stocks ...