FDA/eCTD Format

Enhanced Quality Document Delivery / eCTD Format for FDA Submissions

Infotrieve's Enhanced Quality Document Delivery service cleans up documents
in preparation for FDA submissions.  Our practices follow the eCTD
(Electronic Common Technical Document) procedures as required by regulatory
agencies in the United States and soon to be required worldwide.

Our extensive professional in-house clean up process includes removal of all
black spots, borders, web navigation elements, stickers, and stamps in a
multi-step process using state of the art technology and procedures.

All Documents are reviewed by our Quality Assurance team to ensure accuracy
prior to being delivered to the customer.

Infotrieve will apply these special procedures to documents we have secured
on behalf of a client.

The same high standards can be accommodated for paper delivery if requested.
Paper documents will be reproduced on 24lb high quality paper and will be
clipped, not stapled.

By leveraging Infotrieve's expertise for your FDA submissions, you can be
sure your documents are prepared to meet the exact specifications required
by the FDA expeditiously and cost effectively.

Price: US $10.00 additional per document

For additional details on eCTD format for FDA submissions, click here.