Translational Science Solutions provides a range of services to all sizes of companies developing life science-based solutions that may be subject to FDA regulation, including medical devices, health IT platforms, diagnostics, and combination products. Services and experience include the following:
Identification and evaluation of potential regulatory pathways for pioneering new products under development to determine the most advantageous positioning to meet and exceed both business objective and FDA regulatory requirements.
Assessment and development of product development plans (e.g., regulatory pathway, pre-clinical and clinical evidence requirements) and facilitation of regulatory interactions for to obtain FDA buy-in, reduce regulatory risk, and expedite product marketing.
Guides the overall strategy for communications with and submissions to regulatory agencies such as the FDA on behalf of clients, including the coordination, development, review, and production of:
- FDA Pre-Submission (Pre-Sub) meeting requests
- Investigational device exemption (IDE) applications and protocol review
- FDA 510(k) premarket notification submissions and premarket approval (PMA) applications
- Responses to FDA requests for Additional Information (AI request)
- Review of proposed changes to promotional materials and labeling
- Requests for designation (RFD) for combination products
- Investigational new drug (IND) applications and annual reports
- FDA quality systems inspection training and support
- Comments to the docket for guidance document or new rules proposed by FDA
- Other interactions related to FDA and regulatory positioning