Marc devotes his practice to FDA and DEA compliance, regulatory enforcement and transactional matters in the healthcare and life sciences industries.

He advises pharmaceutical, biotechnology, medical device, dietary supplement, food and healthcare companies on the full spectrum of FDA regulatory issues throughout the product lifecycle, from product development and commercialization to inspections, enforcement and post-market compliance.

Marc represents drug manufacturers, outsourcing facilities, compounding pharmacies, wholesale distributors, third-party logistics providers, healthcare providers and other regulated entities in navigating complex federal and state regulatory requirements.

His FDA practice includes counseling clients on:

• Good manufacturing practice (cGMP) requirements.
• Quality systems.
• Product classification.
• Labeling and promotional compliance.
• Adverse event reporting.
• Import and export issues.
• Recalls.
• FDA inspections.
• Form FDA 483 responses.
• Warning letters, consent decrees and regulatory strategy.

He also advises clients on DEA registration, controlled substance compliance, state licensing and interactions with state boards of pharmacy.

Investigations and Enforcement

Marc regularly represents clients in high-stakes government investigations and enforcement matters involving the FDA, DEA, the Department of Justice, state attorneys general and state regulatory agencies. He guides companies through inspections, import detentions, warning letters, product seizures, injunction actions and other regulatory proceedings, helping clients resolve complex compliance issues while minimizing business disruption.

Transactions

In addition to his regulatory practice, Marc advises private equity sponsors, strategic investors and life sciences companies on mergers, acquisitions, divestitures and other strategic transactions. He leads regulatory due diligence for healthcare and pharmaceutical transactions, identifies regulatory and compliance risks, evaluates licensure and operational requirements, and develops strategies to facilitate successful transactions and post-closing integration.

Drug Shortage and Supply Chain Issues

Marc is particularly recognized for his work involving pharmaceutical compounding, outsourcing facilities and drug supply chain regulation. He works closely with manufacturers, healthcare providers and FDA-registered outsourcing facilities on quality systems, inspection readiness, regulatory advocacy and strategies to address drug shortages and improve patient access to essential medications. He also advises clients on emerging FDA policy initiatives and federal and state legislative developments that shape the healthcare and life sciences industries.

A registered pharmacist with a Doctor of Pharmacy degree, Marc brings an unusual level of scientific and operational perspective to his regulatory counsel. He is also deeply committed to drug shortage policy and works closely with outsourcing facility clients on mitigation strategies.