Reg-Tec, Inc. is an experienced Regulatory Affairs and Clinical Project Management Consulting Company focusing on small to medium-sized, branded and generic pharmaceutical companies. By providing comprehensive drug development services for the ANDA and 505(b)(2) and NDA approval pathways, Reg-Tec, Inc. systematically builds and executes complete development plans that align with business strategies and ensure FDA efficiency every step of the way.
Reg-Tec has over 30 years of experience in global product development for pharmaceutical companies. We have managed over 250 clinical studies in the U.S. and Internationally. We provide studies for CRO’s in Canada, India, Europe, and South Africa, which have resulted in over 100 regulatory approvals.
Medical Device Development
Reg-Tec plans and manages ANDA’s, 505(b)(2's, NDA’s, and 510K’s for FDA submission. In addition, we provide clinical site monitoring; GMP, GCP, & GLP audits; clinical BA/BE study management; regulatory guidance and FDA liaison.