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» » » Strategic Regulatory, Product Development, Quality & Clinical Research Support For Biotech Companies » » »

MDRS, LLC is an FDA registered company that specializes in providing strategic FDA and global regulatory, product development, quality and clinical research support to medical device and biotechnology companies and their development teams.


While MDRS specializes in providing global regulatory support to emergent medical device companies, the firm's clientele include Fortune 500 biotechnology companies and leading Academic Medical Centers that have utilized the firm's regulatory, clinical research and quality systems implementation and remediation services.


We provide comprehensive Total Life Cycle (TPLC) translational development consulting services to assist you in developing and maintaining high quality medical products for global markets.


Our consulting team includes regulatory, product development, clinical research, quality systems and commercialization experts with more than 160 years of combined experience developing and commercializing medical device, pharmaceutical gene therapy and combination products.


We help development teams navigate complex global regulatory requirements and share best practice methodologies associated with successful medical products development and commercialization.


We provide regulatory, product development, quality and clinical research solutions at reasonable rates, so your team can afford early regulatory expertise to help your company develop high quality products with optimal efficiencies for long term success. Contact us today to learn how we can best support your team.  

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