Your regulatory affairs organization must collect, assemble and publish a large volume of submission data and analyses, often from a wide variety of reliable sources.
After the initial submission is complete, its full lifestyle must be managed. This includes all incremental sequences and amendments produced as a result of agency requests for clarification, changes in indications, etc. It’s necessary to validate your dossier not only at different stages of the life cycle, but most importantly, before submission, to verify compliance with current regulatory guidance.
As your trusted advisors on all things eCTD related, we offer you the following current best practices for the submission validation:
1. UNDERSTAND THE VALIDATION CRITERIA OF THE HEALTH AUTHORITY
Health Authorities in Canada, Europe and the U.S. each have their own set of eCTD validation criteria published on their websites. Understanding validation criteria for your market makes it easier to detect errors considered critical by the Health Authority to which you’ll submit. Be sure to go to the relevant website and do your homework so that you know that you’re giving the Health Authority exactly what it wants and needs.
2. UNDERSTAND THE CAPABILITIES OF YOUR TOOLS
While your publishing tool may detect some errors, chances are it will not detect all errors considered important by every Health Authority. Supplemental validation tools such as GlobalSubmit’s VALIDATE can help you increase your submission confidence and avoid Health Authority refusal. If you don’t have 100% critical error coverage in your tool suite, you’ll need to perform manual checks, which are time consuming and labor intensive. Be that as it may, you must conduct thorough manual checks if your electronic validation tool doesn’t provide the error checking and solution criteria you need.
3. DO NOT MANUALLY EDIT YOUR XML
It’s easy to get your publishing tool “out of sync” with your submission when you edit eCTD XML code manually. There are many tools on the market designed to check the structural integrity of your XML. Be sure to use an automated tool to avoid unnecessary technical errors.
4. CORRECT ALL ERRORS BEFORE DELIVERING YOUR SUBMISSION
Many companies do not correct errors because they think those errors aren’t critical. They should probably think again. By correcting all errors prior to submission, you certify that you have not missed a single critical error. A good way to summarize and categorize your errors is to run a validation tool prior to your submission. Our VALIDATE tool provides not only error checking, but also robust reporting that allows you to summarize and systematically correct all errors.
Want to know more? Contact us at 888-840-9580.