Review and gap analysis of a technical file
A pharmaceutical company wanted to launch a drug delivery device in the United States. The product was approved in the EU and Team Consulting was commissioned to review the technical documents and ensure its suitability for a submission to the FDA.
Drawing on from many years of drug delivery device experience, we put together a team comprising of quality engineers, risk management experts, device testing specialists and human factors consultants to conduct a review of the available documents. In addition, we proposed options to fill any gaps in data or documentation that could prevent or delay FDA approval.
The combination product was approved by the FDA in a timely manner with minimal changes to existing documentation.