505(b)(2) NDA Preparation Process
- Posted by: Ken Phelps
- Published on: January 26, 2010
Camargo is fully prepared to create, submit and manage the review of an NDA, either 505(b)(1) or 505(b)(2). Generally, we submit the NDA electronically, so we’re submitting an eCTD.
1. An individualized secure shared website for Camargo and the Client’s project is created for document control. A folder structure is set up according to the Client’s needs and the project management plan. The Client’s team has access for document upload, review and approval.
2. For an NDA, the individual documents are created (either by Camargo or the Client, per agreement) as designated by FDA’s Guidance on CTD Granularity. Ancillary documents, such as Batch Manufacturing records or Study Reports are uploaded to the site as well. An agreed upon series of reviews and revisions takes place. Document integrity is maintained by the check out requirement for revision (See, small green arrows in section 2.7.3 and 2.7.4 in the screenshot below) as well as a specific revisioning function, which preserves all versions and indicates when and by whom changes are made.
3. Documents which are complete and final are organized according to the appropriate Module for upload into the eCTD software.
4. Once files and required support documents are uploaded to the eCTD manager, hyperlinking and bookmarking can take place. Once complete, the eCTD is validated, and then can be published, at which point the XML backbone is installed. The NDA is ready for submission.
After submission, amendments are made using the same process. The eCTD manager maintains all of the amended changes.
In addition to NDA’s, Camargo uses the exact same process for ANDA submissions.