Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format ...
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 "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" webinar has been added to ResearchAndMarkets.com's offering. This four day webinar series (each day 3 ...
DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official" conference has been added to ResearchAndMarkets.com's offering. The ...
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 ...
HORSHAM, Pa., July 18, 2023 /PRNewswire/ -- LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management and analytics solutions for the life sciences industry, is expanding ...
As the FDA deadline for eCTD submissions approaches and the complexity of drug development continues to increase, life sciences companies need sophisticated and easy to use tools that help them ...
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 ...
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