Regulatory Compliance for Life Sciences
Regulatory compliance presents the biggest hurdle for life sciences companies. Nelson Hardiman attorneys advise these businesses on Medicare, U.S. Food and Drug Administration (FDA), HIPAA and clinical research compliance. We have defended numerous investigations relating to compliance and fraud and abuse issues. Our strong experience gives us the in-depth understanding to assist clients in product development and regulatory approval, including issues related to third-party payor reimbursement across the life sciences industry.
Our clients include medical device manufacturers and resellers, biotechnology companies developing new drugs, biologics, medical foods, and other therapies, and manufacturers and resellers of “nutraceutical,” “cosmeceuticals,” and supplements. We leverage our regulatory know-how to help clients develop and maintain regulatory compliant life sciences companies. Clients count on Nelson Hardiman to make sure their businesses are protected from regulatory risks and to help structure dynamic new business ventures.