Depending on the type and progress of your development, there are a number of submissions that may be required by the FDA for approval. We will work with you to develop submissions and applications designed to meet FDA requirements and concerns.
QST has the expertise necessary to successfully guide your medical device or pharmaceutical through the various stages of the regulatory process. We work with our clients to help meet deadlines, ensure compliance and prepare meetings with the FDA.
FDA Submission Services
- IND filing and NDA (including BLA, ANDA, 510(k), PMA, etc.) preparation in eCTD format
- Submission including updates via DVD or Electronic Gateway