DMF Agent Service Online Renewal
In order for Registrar Corp to continue to continue to serve as your firm’s Drug Master File Agent, you must renew our service for the period of June 1, 2017 to May 31, 2018.
Registrar Corp’s DMF Agent service includes the following at no additional charge:
- DMF Submissions: Assistance submitting Annual Reports, Amendments, Letters of Authorization, Withdrawal of Letters of Authorization, Closure Requests, Transfer Requests and Acceptance Letters by paper or eCTD
- Deficiency Letters: Registrar Corp facilitates communication between FDA and your company to resolve deficiencies and submit the responses to FDA as a paper or eCTD amendment
- eCTD Filing: FDA will require all DMF submissions to be in electronic common technical document (eCTD) format beginning May 5, 2018. Registrar Corp can convert your DMF submissions from CTD to eCTD format.
- DMF Certificates: Certificates issued by Registrar Corp provide confirmation to industry that you have filed Drug Master Files with FDA
To renew your firm’s DMF Agent service with Registrar Corp, please complete the following information: