SERVICES
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 clinical study 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
Breakthrough Device Designation (BDD) requests
Comments to the docket for guidance document or new rules proposed by FDA
Other interactions related to FDA and regulatory positioning