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 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 ...
Freyr Solutionsが、日本の製薬業界関係者向けに無料の対面型ワークショップを開催。実践的なトレーニングと専門家の解説で、eCTD v4.0移行を力強くサポートします。 Freyr Life Sciences 株式会社 2025年7月31日 09時30分 日本は、世界で初めてeCTD v4.0を正式導入する国 ...
BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and ...
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 ...
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