RegChoice can help you at any stage of drug and biologic development. Whether you need help regarding guidance/strategy, review, scientific writing, literature search and review, compilation, submission, regulatory correspondence, postmarketing/safety, or have any other potential concerns along the development, marketing, and/or regulatory path, please reach out. Our vast experience will be put to good use.
We can assist with any demands during preclinical and clinical (Phases 1-4) product development including design and interpretation of preclinical and pivotal clinical trials. Some of our work has been to complement Special Protocol Assessments (SPA) and additional FDA pathways. In order to bring their products to market, our clients rely on us to interact with FDA and submit the proper eCTD documentation through the electronic portals. Our full product development services have also included reviews of OTC and prescription product labeling and marketing, promotional and educational materials as well as post launch planning.