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.
What is this resource?
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.
Review the original project for installation steps, licenses, compatibility and updates. This directory provides discovery links, not downloadable or verified code.
Installation
For repositories supported by the Skills CLI, you can typically start with:
npx skills add aipoch/medical-research-skillsCheck the repository instructions and select the intended skill before installing. This command may not apply to every source.
Safety & attribution
This is an external resource, not independently security-audited by this directory. Inspect permissions, scripts and changes before using it with your files or accounts.