FDA APPROVAL AND COMPLIANCE

 

strategic and technical expertise

Polsinelli Healthcare Solutions collaborates with clients in the life sciences industry to effectively and efficiently bring FDA-regulated products to market. For companies working in all sectors of the life sciences industry, converting innovation into approved product is essential to market acceptance, reimbursement and long term success. 

We provide strategic, technical and policy-related advice to companies throughout the life sciences ranging from medical devices, diagnostic and therapeutic pharmaceuticals, biologics and combination products, cosmetics and emerging digital health technologies and applications. Advisors on our multidisciplinary team deploy their practical industry knowledge gained through extensive agency and public policy experience to support clients in the pre-market and post-market environments. We work with a number of FDA consultants to support the paper-intensive and hyper-technical aspects of client assignments.

 
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FOOD AND DRUG ADMINISTRATION APPROVAL AND COMPLIANCE Solutions

Polsinelli Healthcare Solutions advisors provide tailored advice and solutions to address the FDA needs of life science companies, including:

  • Providing strategic advice on regulatory pathways to market

  • Addressing policy barriers to market through advocacy before the FDA and Congress, including through citizen petitions and other activities to support policy initiatives

  • Preparing pre-market applications to the FDA for 510(k), BLAs, NDAs and ANDAs

  • Advising clients how to remain compliant in the post-market environment

  • Assisting with policy and procedure development and refinement to meet FDA record-keeping, quality system regulation and other requirements