DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. The international agreement to assemble ...

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 ...

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 ...

Dublin, Oct. 16, 2019 (GLOBE NEWSWIRE) -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. This two day workshop ...

You need to enable JavaScript to run this app. RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use ...

EMC this week announced Document Submissions Manager for electronic common technical document (eCTD) software, designed to simplify the management, assembly, and delivery of drug applications to ...

10545 This course will offer insight into the compilation of the eCTD, share experience and best practise gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on ...

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 ...

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 ...

French health authority confirms it is currently returning 50% of NeeS regulatory submissions because of failure to conform to published standards, as Europe moves away from paper dossiers DIA - ...

The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. The international agreement to assemble all Quality, Safety and ...