The Electronic Common Technical Document (eCTD) is the standard format for submitting regulatory submissions to the U.S. Food and Drug Administration (FDA) and other health authorities around the world. It is a structured electronic document that contains all of the information necessary for a regulatory authority to review a drug application, such as nonclinical and clinical data, manufacturing information and labeling.
The FDA requires that all new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) be submitted in eCTD format. The FDA also requires that certain other regulatory submissions, such as amendments, supplements and reports, be submitted in eCTD format.
Why Reed Tech for eCTD?
Pharmaceutical companies and biotech firms can benefit from outsourcing eCTD publishing and submission preparation. Gain peace of mind by engaging Reed Tech for eCTD services, while your staff focuses on other core business activities.
Allow Reed Tech to ensure submissions are compliant with regulatory technical eCTD requirements and standards. We utilize our experience, technological innovation, software integration and the support of our people to become an expert extension of your regulatory team. Pair our many regulatory services together for a convenient, streamlined solution.