Regulatory

The Life Sciences Practice assists innovators in developing comprehensive regulatory strategies for conducting scientific and medical testing of innovations to prepare applications, respond and reply to objections, and obtain approval from federal and state agencies to market a life sciences innovation. Our attorneys and scientists have experience with regulatory matters governed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) as they relate to human, plant and animal technologies. In addition, our Life Sciences attorneys and scientists work closely with Spencer Fane's securities regulatory attorneys when such regulations impact the development of your life sciences technology.

We also work with a network of outside consultants and business advisors having expertise in regulatory matters pending before the FDA, USDA, EPA, Drug Enforcement Agency, Federal Trade Commission, Office of the Inspector General of the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, Consumer Products Safety Commission, and other federal and state agencies. In combination with this network, the Life Sciences Practice is able to counsel clients concerning statutory and regulatory requirements, including product approval and safety issues, current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) requirements, regulatory strategies and life cycle management, labeling, advertising, import/exports (including ITAR and EAR regulations), clinical investigation requirements, product liability, market protections (e.g., Waxman-Hatch exclusivity, orphan drugs, and patent term extensions), and enforcement issues.

Our Life Sciences attorneys and scientists are able to work with a business's collaboration partners, including contract research organizations (CROs) and contract manufacturing organizations (CMOs), that conduct experimental and analytical work to further develop the technology. By leveraging information and technical data provided by CROs, CMOs, and the innovator's internal efforts, a comprehensive intellectual property strategy can be developed that protects what the innovator predicts will reach the market. In addition, by combining regulatory and intellectual property strategies that leverage collaborative efforts, a business may reach proof of concept, pass investors' due diligence, and begin the pre-clinical trial or drug application process at an earlier stage. All of these aspects of the comprehensive strategy can enhance the value of the life sciences innovation.