We help you comply with FDA regulations.
We’re committed to quality, accurate and timely service.
Secord Inc. brings over 20 years of experience in regulatory affairs and quality assurance. With cross-industry experience, Secord has handled submissions for diverse dosage forms, as well as interactions with multiple therapy areas. We have worked with all FDA-regulated products, and have experience with prescription small and large molecules as well as consumer drugs and devices, including fast track and accelerated review applications. We’ve also managed large electronic submission projects.
We have extensive experience working with the FDA. We have requested and assisted our clients in Type A, B and C meetings with several Divisions. We have also submitted Orphan Drug Designation applications and helped develop presentations before Advisory Committees and submissions of NIH Appendix M applications. To date, Secord has been involved in the development of numerous INDs, NDAs, BLAs (paper and electronic), ANDAs/505b2 applications and 510k applications.
We are a company led by regulatory affairs and quality assurance experts with industry-wide experience. Working with Secord Inc. is a smart investment. In addition to working with our clients to achieve compliance, we help our clients enhance efficiency and cut costs.