Organizations considering the move to eCTD have to decide whether to prepare submissions in-house with a publishing tool or outsource to a publishing partner. The costs and risks associated with acquiring software, developing processes, training staff and actually performing eCTD publishing may not be justified based on expected submission volume. In this case, your organization should contract with a partner company to produce and submit eCTDs.
Some items to keep in mind when choosing a partner...
1. What is the partner's experience in your target market(s)?
How many applications and sequences have they submitted? What application types (IND, NDA, BLA, DMF, ANDA) have they handled?
2. How will the work be divided between you and your partner?
For example, will they scan documents, update MS Word documents to meet standards, publish study reports, create cross-references or submit to the gateway for you?
3. What quality control standards will your partner use?
Ask to see their quality control checklists for documents and for the submission as a whole.
4. How will your partner validate the eCTD? What checks will be made?
Ideally, the partner's validation process should guarantee 100% of the validation checks for your submission market. Be certain that you understand how this will be done and if any checks will be manual. Make sure to discuss what happens if a submission is rejected due to technical errors.
5. How will you QC the submission after the partner has prepared it?
Will you be given access to an eCTD viewer (QC of files on the file system is unacceptable)? How will the submission be delivered back to you?
6. To what extent will your partner act as a trusted adviser?
Will they be able to advise you on best practices, answer your questions and guard against common issues encountered with the eCTD?