Services

Regulatory Affairs

GRS is well positioned to serve you with regulatory filing required for approval in multiple countries across the globe. As a result of managing a large number of clinical trials worldwide, GRS has gained significant global regulatory experience. We have managed regulatory approval of trials in over 40 countries across North America, Latin America, Europe, Asia, and Africa. GRS has a streamlined process for the proper collection of regulatory documents, which eliminates errors and requests for corrected documents. GRS tracks, reviews, processes, stores and follows up to ensure the collection of all regulatory documentation. In addition, GRS tailors regulatory submission for each study site to optimize study start-up, reduce lead time required to enroll subjects and tracks all IRB/EC submissions and decisions to provide up-to-date metrics on approval status. We've also gleaned enough international regulatory experience to provide effective submission strategies by submitting documents in parallel to Central and Local IRBs/EC and regulatory agencies when appropriate. We've refined the regulatory submission process to bring more value to our clients.