We advise large and small pharmaceutical and health care companies in the U.S. and worldwide on environmental and product-related matters.
Companies in the pharmaceutical, biotechnology, medical device, and health care sectors operate in an increasingly complex regulatory environment. Environmental compliance obligations, product stewardship requirements, manufacturing standards, sustainability initiatives, and heightened enforcement and litigation risks can all affect business operations, market access, and corporate reputation.
Our lawyers guide clients through these challenges with practical, business-focused advice informed by decades of experience counseling highly regulated industries. We combine deep experience in environmental law, product regulation, litigation, enforcement defense, and scientific and technical matters to provide practical, business-oriented counsel tailored to the unique needs of highly regulated industries.
Whether addressing emerging chemicals regulations, manufacturing compliance obligations, sustainability initiatives, supply chain requirements, or environmental enforcement matters, we help clients anticipate challenges, respond effectively, and position their businesses for long-term success.
Our Experience Includes
- Product stewardship and global supply chain compliance, including conflict minerals, batteries, and other emerging product-related requirements
- Chemicals regulation and chemical notification, reporting, and inventory requirements
- FDA regulatory matters involving medical devices and pharmaceuticals, including manufacturing standards, clinical and pre-clinical testing requirements, product recalls, and market withdrawals
- Air, climate, and greenhouse gas regulations, including permitting and compliance under the Clean Air Act and related federal, state, and international regulatory programs
- Water quality, wastewater, and stormwater compliance, permitting, and enforcement matters
- CERCLA, RCRA, EPCRA, hazardous materials, and waste management requirements
- Occupational safety and health (OSHA) compliance, inspections, incident response, and enforcement defense
- Hazardous materials and dangerous goods transportation
- Environmental audits, environmental management systems (EMS), and compliance assessments
- Sustainability, ESG, circular economy, extended producer responsibility (EPR), recycling, and product take-back initiatives
- Internal investigations, government inquiries, enforcement proceedings, and crisis response
- Product liability, toxic tort, mass tort, and commercial litigation involving regulated products and operations
- Environmental due diligence, transactions, and facility acquisitions
- Complex international regulatory frameworks affecting products, facilities, and operations
