7kngxjuaqfi5ddl1imk2 reg tec new logo

Reg Tec, Inc.

ic No Reviews Yet
ic No Completed Orders
Lake Wylie, South Carolina, US

About Reg Tec, Inc.

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... Show more »

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.

Show less

Diversity Certificates

Small business

Our Services (8)


ic

Clinical Development Strategy

Price on request

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 assists companies with: product opportunity assessment & evaluation; regulatory feasibility reviews; tech transfer evaluation and implementation; contract negotiations; and facilitation of support services.

Show less

ic

Regulatory Affairs Services

Price on request
Request a quote for more information about this service.

ic

Feasibility Studies

Price on request
Request a quote for more information about this service.

ic

Project Management

Price on request

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.

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.

Show less

ic

Technology Transfer and Licensing

Price on request
Request a quote for more information about this service.

ic

Clinical Site Auditing

Price on request
Request a quote for more information about this service.

ic

Clinical Trial Design and Consulting

Price on request
Request a quote for more information about this service.

ic

Clinical Trial Management

Price on request
Request a quote for more information about this service.

Not finding what you're looking for?

Get info on this provider's capabilities without requesting a quote.

Reg Tec, Inc. has not received any reviews.

Reg Tec, Inc. has not received any endorsements.