dossier prepoaration in both ctd as well as actd format

Question

Accepted Answer

Dossier preparation involves creating regulatory documents in both CTD and ACTD formats.

Dossier preparation is a crucial step in the regulatory affairs process.
CTD (Common Technical Document) format is widely used in regions like the US, EU, and Japan.
ACTD (ASEAN Common Technical Dossier) format is specific to the ASEAN region.
Both formats require organizing and compiling relevant information and data.
Dossier preparation includes sections like quality, nonclinical, clinical, and regulatory information.
Examples of documents in a dossier include drug product information, manufacturing details, clinical trial data, and labeling information.

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