REGULATORY STRATEGY, SUBMISSIONS & MEETINGS

ISS specializes in providing insight and knowledge of the regulatory process as well as integrated approaches that maximize the potential for success while minimizing approval time. ISS helps to prepare persuasive regulatory submissions based on sound scientific data. This includes the design and development of INDs, IDEs, 510(k)s, NDAs as well as comprehensive scientific substantiations for product claims.

 

RX – OTC Switch: ISS is a leader in pursuing the most challenging, cutting edge RX – OTC switches, and achieves this through a robust understanding of the dynamic between consumers, regulators, investigators, and the medical community. 

 

Issue Management / Outreach Programs: ISS builds initiatives and outreach programs that facilitate product acceptance and market success, as well as influence prescribing behavior.

 

Dietary supplement Claim Substantiation and Ingredient Safety Reviews: ISS is an expert in developing rigorous claim substantiation assessments, ingredient safety reports, formulation reviews and promotional material reviews for over-the-counter monograph drugs, dietary supplements, cosmetics and consumer product manufacturers which were submitted to regulatory bodies, such as the National Advertising Division (NAD), US Food & Drug Administration (FDA), and the Federal Trade Commission (FTC).