List of Contributions

Dear RA community, Can anybody suggest preferred vendor for eCTD templates catered towards cell and gene therapy INDs? I am looking for templates which comes with the instructions written for cell and gene therapy INDs, particularly for CMC sections. Most available eCTD templates have instructions ...

Dear Regulatory Community - I was hoping that someone here can provide me some insight from their experience with SEND data sets for non-clinical studies. As per the guidance "Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, ...