REgulatory Affairs

At the outset of your development plan, sound advice from a Regulatory Consultant is critical.

The Regulatory Affairs team at CDS has the real world experience to guide you in the best strategic direction, saving valuable time and resources.

From strategic planning to submission, CDS offers complete Regulatory Consulting services:

Regulatory planning

New Drug Applications (NDA’s), Abbreviated Drug Applications (ANDA’s), Supplemental New Drug Applications (SNDA’s)
Clinical Trial Applications (CTA’s)
Label and Advertising Review
Drug Master Files (DMF’s)
Other Regulatory Compliance Issues

Clinical Development Solutions

GVI Clinical Development Solutions is a Clinical Research Organization (CRO) providing high quality clinical and regulatory support to biotechnology, pharmaceutical, diagnostic, medical device and nutraceutical companies.

CDS offers customized services including: Clinical & Regulatory Strategy Development, Regulatory Affairs & Submissions, Clinical Trial Monitoring, Project Management, Clinical Document Control, Pharmacovigilance and Quality Assurance.

Under the guidance of our detailed Quality Management System, our experience sets us apart allowing us to deliver to our customers quality data in a shorter period of time and at a lower cost than other CROs.