Legal & Compliance

Regulatory Submission

Prepare FDA/EMA regulatory submissions (IND/NDA/BLA/510(k)/PMA/MAA) in CTD format. Generate module outlines (Modules 1-5), run ICH compliance checks (ALCOA+, E6 GCP, Q1-Q12), verify data integrity, and produce submission-ready dossiers with cover letters and checklists.

Publisher / source

aipoch/medical-research-skills (found on GitHub top repositories)

Upstream record

aipoch/medical-research-skills

Version

Version 1

Published

2026-11-07

Publication review

Approved for publication · recorded passed scan 2026-11-07

Content fingerprint

579f8dc0966353a787794774b68ed208af65d945b8711f8a1a4b4dcbbb2c84b6