Advanced Consulting Services for the Pharmaceutical Industry


Regulatory Affairs

regulatory-affairs

Our Regulatory Affairs services are wide-ranging with a focus on FDA-related tasks.  A highly experienced group of consultants will coordinate to help your projects move as quickly and as smoothly as possible, while at the same time insuring that your financial obligations are minimized.

We are experts in a variety of FDA registration activities including PDUFA user fees (Prescription Drugs), GDUFA user fees (Generic Drugs), Establishment Registration, Drug Registration and Listing (NDC Code), Labeler Codes, and Importers of Record just to name a few.  We maintain an Electronic Service Gateway (ESG) with the FDA and pride ourselves in offering an excellent level of service.  We serve as the U.S. Agent for foreign facilities as mandated by the FDA, and have successfully assisted numerous clients with PDUFA fee waivers or refunds.

Our services include eCTD-compliant publishing, maintenance, and electronic document submission.

We can oversee and support many types of FDA submissions, including:
Drugs Medical Devices Foods and Supplements
ANDA 510(k) New Dietary Ingredients
DMF Food Additive
NDA PMA Food Contact Substance
Supplements (CBE-30, PAS) GRAS Notification