Natalie C. Oehlers Associate

Natalie counsels clients on complex regulatory, transactional, and strategic matters across the healthcare and life sciences sectors, focusing on pharmaceuticals, medical devices, cosmetics, food products, dietary supplements, and cannabis-related products.

This includes advising on business and product development strategies, clinical trial compliance, emerging federal and state regulatory frameworks involving artificial intelligence and machine learning, enforcement and compliance concerns, and marketing risk analyses involving the Anti-Kickback Statute, False Claims Act, and related laws. Natalie also assists or otherwise interacts with various federal agencies, and their state-level counterparts, including:

• Food and Drug Administration (FDA)
• Centers for Medicare & Medicaid Services (CMS)
• Drug Enforcement Administration (DEA)
• Federal Trade Commission (FTC)
• United States Department of Agriculture (USDA)
• Center for Disease Control and Prevention (CDC)

Additionally, Natalie advises on pre- and post-approval commercialization such as market planning, marketing and promotion, pricing and rebate strategies, and supply chain readiness and related contracting.

Moreover, Natalie has worked closely with a variety of other industry teams to support a client’s overall goals. This includes government relations teams to draft, evaluate, and advocate for legislative, regulatory, and policy changes affecting the healthcare and life sciences sectors. It also includes working with intellectual property teams to conduct FDA-focused due diligence to support investment decisions and product portfolio expansion as well as provide regulatory support for Hatch-Waxman litigation.