Reg Tec has over 30 years experience in global clinical development with CRO’s and pharmaceutical companies. We have secured and managed over 250 clinical studies in the U.S. and Internationally.
Reg Tec has represented International CRO’s in the U.S. market for over 20 years. We provide studies for CRO’s in Canada, India, Europe and South Africa, which have resulted in over 100 regulatory approvals.
Reg Tec assists companies with: product opportunity assessment & evaluation; regulatory feasibility reviews; tech transfer evaluation and implementation; contract negotiations; and facilitation of support services.
Reg Tec plans and manages: ANDA’s, 505(b)(2) 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 act as a FDA liaison.
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