New Drug Discovery and developments-Pharmaceutical regulatory affairs-2024 Background-New Drug Discovery and developments Drug discovery is a complex and multi-step process that involves identifying chemical compounds …
EU IDMP Implementation Guide -2_Data elements for the electronic submission of information on medicinal products for human use EU IDMP Implementation Guide -2_Data elements for …
Certification of suitability:New requirements for CEP to the Monographs of the European Pharmacopoeia CEP dossier 2.0 New requirements for the content of the CEP dossier …
TGA-eCTD format Submitting data – Australia-2024 Submitting data in the eCTD format – TGA – Australia-2024 , The following guidance is intended for sponsors and …
Health Canada 13 may has issued guidance regarding the preparation of regulatory submissions in formats other than eCTD, instructions for electronically filing these submissions “Health …
The European Union (EU) Clinical Trials Regulation The European Union (EU) Clinical Trials Regulation (CTR) is a regulation that aims to simplify and harmonize the …
Regulatory affair eCTD compilations eCTD compilations The electronic common technical document (eCTD) is a standard format for submitting regulatory affairs documentation to regulatory authorities such …
CMC regulatory affairs: An introduction to CMC and compliance CMC regulatory affairs CMC Regulatory affairs is an important component of the development and approval of …
eCTD Regulatory affair & ICH-GCP eCTD Regulatory affair & ICH-GCP Regulatory affairs is a critical component of clinical research and drug development, as it involves …
Module 5 clinical summary report regulatory submission module 5 on clinical summary reports. Module 5 clinical summary report regulatory submission , A clinical summary report …
