An initial marketing application submission is a major undertaking that requires a large team, numerous tools and a litany of subprocesses to work together in harmony for a successful outcome. Leaving ...
DUBLIN--(BUSINESS WIRE)--The "Filing eCTD Submissions" conference has been added to ResearchAndMarkets.com's offering. The eCTD (electronic Common Technical Document) is now mandatory for submissions ...
An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents ...
The U.S. Army Medical Research and Materiel Command's Enterprise Information Technology Project Management Office helped the U.S. Army Medical Materiel Development Activity submit its first in-house ...
Dublin, Nov. 14, 2025 (GLOBE NEWSWIRE) -- The "The Common Technical Document (CTD) Submission in the MENA Region Training Course (Nov 28, 2025)" training has been added to ResearchAndMarkets.com's ...
PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence solutions, today announced that the US Food ...
Full Suite of Products and Services Navigate Evergreen Regulatory Environment Whippany, NJ - September 3, 2010 - Last year, the pharmaceutical industry in the Association of Southeast Asian Nations ...
Full Suite of Products and Services Navigate Evergreen Regulatory Environment Whippany, NJ - September 3, 2010 - Last year, the pharmaceutical industry in the Association of Southeast Asian Nations ...