CONSULTING AND OPINIONS FOR REGULATORY RELATED SERVICES FOR CONTRACEPTIVE RESEARCH

Investigators

Abstract

The Contraception Research Branch has several grant awards and contracts that focus on the development of new contraceptives for men and women – each project has a regulatory requirement. There is a clear benefit to increasing Program’s understanding of these requirements for identified applications and funded awards. There is also a benefit to increasing the field’s knowledge on this topic overall. Only a person skilled in regulatory requirements can provide the critical insight into commenting, designing, packaging, and submitting applications to regulatory bodies can inform Program in making scientific decisions to meet the government’s goal: new contraceptive options for men and women. Mr. Gamerman of Seraphim Life Sciences Consulting has several years’ experience providing opinions for regulatory requirements on developing technologies (e.g., drugs and devices), including contraceptives.