Question:
What is the recommended process for generating and submitting a 2253 Form in Vault?
Answer:
When using any Vault with no 2253 Form feature, the recommended process starts by manually assembling an eCTD (electronic Common Technical Document) binder. After the assembly into an ESG (Electronic Submissions Gateway) package and submission, the documentation should be stored in Submissions Archive Vault.
In case of having both PromoMats and RIM, the 2253 Form is generated in PromoMats and the rest of the information is gathered in RIM. After the assembly into an ESG package and submission, the documentation should be stored in the Submissions Archive Vault.
Related Documentation:
Vault 2253 Documentation: