FDA Regulatory + Life Sciences Compliance

From developing communications strategies to guiding you through an enforcement or recall situation, and everything in between, we are your complete life-cycle counsel for navigating compliance with regulated products.

We advise clients in the life sciences and healthcare industries, helping them navigate complex regulatory, compliance, healthcare system, and marketplace issues. With a strategic and comprehensive life-cycle approach, we counsel domestic and international clients, from pre-product launch to post-market representation in the medical device, pharmaceutical, food and dietary supplement, biotechnology, healthcare technology, and cosmetic industries, ensuring that our clients are U.S. FDA-compliant and optimally positioned for maximum coverage and reimbursement, entry into new global markets, and further research and development. We have particular strength in cutting-edge technology areas such as life sciences data analytics, precision medicine, software as a medical device, robotics, and cellular therapies.

Our clients include:

  • Emerging companies looking for regulatory pathway development and strategic alignment with critical business goals
  • Private equity firms and other investors requiring specialized diligence and transactional support in the highly regulated life sciences and healthcare industries
  • Companies needing regulatory counsel regarding product labeling, advertising, and promotion and development of strong compliance programs
  • Product developers requiring guidance on federal and state regulatory laws impacting product design, commercialization strategy, and product launch
  • Life sciences and medical technology sponsors seeking to engage effectively with the FDA through strong strategies and clear submissions
  • Academic medical centers and technology transfer groups seeking to maximize the value of their technology through strong regulatory strategies and actions
  • Regulated businesses facing product recalls, government investigations, and litigation
  • Trade associations seeking to shape policy or influence the overall system on behalf of their members
FDA Regulatory Advice

At the core of our practice is the focus on compliance with the U.S. Food, Drug & Cosmetic Act and all of the implementing regulations and guidance documents enforced by the FDA. We advise clients all over the world on pre-market regulatory issues, helping clients develop viable regulatory strategies and implement them through strong submissions and clear communications with FDA. We advise clients on the vast regulatory requirements, ethical challenges, and practical concerns they will face in preclinical, clinical, and research settings. We provide full life-cycle advice, addressing post-market issues such as labeling and promotional campaigns, product modifications, manufacturing quality programs, supply chain management and distribution controls, and dealing with product recalls. Our team regularly handles FDA inspections and Warning Letter responses in addition to many other types of significant enforcement actions.

Product Reimbursement

Regulatory and contractual requirements governing healthcare reimbursement are growing increasingly complicated. We help our clients develop product reimbursement strategies that look at coding, coverage, and payment issues and keep an eye on the intersection of FDA regulatory strategy and long-term reimbursement goals.  We bring a unique perspective to product reimbursement strategies, assisting with code selection and assignment, evaluation of coverage and reimbursement limitations, and assessment of reimbursement implications across other areas of product compliance. We have worked with our clients on commercial payor audits and overpayment assessments, government investigations and litigation involving reimbursement issues, and compliance with billing and coverage requirements imposed by government and commercial payors. 

Life Sciences Regulatory Compliance

We recognize that FDA regulatory compliance is only one piece of the complex set of regulations impacting a life sciences business. We advise clients on the design and implementation of compliance programs that address fraud and abuse, labeling and promotion, and various reporting obligations. Our team assists with complex internal investigations and responding to governmental enforcement actions relating to the full range of life sciences regulations, such as compliance with the anti-kickback statute, transparency reporting, clinical trial compliance, and privacy. We provide sales force training, participate in promotional review teams, and regularly dig deep into the complexities of implementing a viable compliance program within a full range of companies—from startups to large international companies.

Strategic Policy Advice

Strong relationships with the FDA and on Capitol Hill are a crucial piece of the regulatory compliance puzzle. We leverage our deep connections honed through years of working with the FDA and policymakers to interpret and influence the policymaking process and develop solutions to help our clients bring products to market, maintain compliant operations, maximize profitability, and benefit patients. Through our advocacy and the combination of policy and legal approaches, we are successful in educating policymakers about the practical challenges that life sciences and healthcare organizations face.

Consistent with the firm’s collaborative approach, we work seamlessly with other lawyers across the firm to meet our clients’ comprehensive needs regarding FDA regulations, compliance, enforcement, policy, and strategic counsel:

  • We leverage the Technology Transactions, Patent, and Privacy Groups into a focused team to work on life sciences data analytics issues, including big data ownership, real world evidence generation, and complex uses of data with tools like AI and machine learning.
  • We work with our Global Privacy + Data Security team on HIPAA, connected health, telemedicine, and clinical trial compliance matters.
  • We partner with our Product Liability team to provide advice on regulatory compliance, product labeling, and litigation risk assessment, including guiding clients through complex product recalls, counseling on insurance and indemnification issues, and advising on acquisitions involving ongoing product liability claims.
  • We collaborate with our Corporate team to manage risk and compliance issues in financing, M&A, and IPO transactions.
  • We work with our IP team to ensure our clients’ innovations are well positioned for timely regulatory approval while maximizing the value of a commercial launch.

This integrative approach provides our clients with the highest quality counsel for developing cutting-edge solutions that ensure product compliance and maximal market potential.

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