Regulatory Strategies and Solutions, Inc. can assist clients in medical device, combination product, and pharmaceutical drug development by providing regulatory support for the ultimate approval of your products.Our experience in bringing new products to market can provide value to your organization in a variety of ways.Let us assist you in:
Planning successful interactions with FDA or International Agencies
Strategic discussions for drug, device and combination product development
Preparation for meetings with regulatory bodies
Pre-clinical, Clinical and Quality (CMC) support
Drug, device and combination product approvals
Technical document writing for IND’s, IDE’s, NDA’s, and PMA’s
Internal training
Due diligence activities
Regulatory related submissions (electronic or paper format)
Manufacturing and cGMP compliance activities
Handling scheduled drugs
We can provide you support for all your regulatory needs!
