Our Life Sciences Regulatory & Compliance team is dedicated to helping clients effectively navigate today’s regulatory landscape so they can focus on meeting business objectives.
We provide regulatory and compliance advice tailored to the unique needs of clients in the pharmaceutical, biologic, medical device, diagnostic, laboratory testing, and digital health industries. This includes strategic counseling, advocacy, and representation in connection with all manner of regulatory and compliance needs — including comprehensive support throughout every stage of a medical product's life cycle.
Lawyers on our team have deep and diverse experience, including having served as former regulatory counsel at the FDA, in-house senior executives in legal and compliance roles at multi-national medical products makers, and roles in global trade associations and management consulting. We bring a 360-degree perspective to the pressing legal, regulatory, and compliance issues that affect our clients.
We also advise on corporate transactions of all sorts, including IPOs, M&A, and licensing deals, and support investors on potential investments in life sciences. And we represent leading trade associations and offer counsel on policy and legislative issues to clients appearing before the FDA, the Centers for Medicare & Medicaid Services, the U.S. Department of Health and Human Services Office of Inspector General, Congress, and other policymakers.
Connect with our Life Sciences Regulatory & Compliance team and let us know how we can help.
Our Comprehensive Offering
We advise on pre-market strategy and implementation, including in areas such as:
- Product development
- Clinical investigations
- Expedited review and approval pathways
- Orphan drug and other designations
- Pre-market applications (e.g., NDAs, 505(b)(2)s, ANDAs, BLAs, biosimilars applications, 510(k)s, de novo requests, and PMAs)
- Dispute resolution and appeals
- Label negotiations
- Commercial launch preparation
- Inspection readiness
- Assessment of exclusivity protections
We advise on a full spectrum of post-market issues, including those related to:
- Labeling
- Advertising and promotion
- Adverse event reporting
- Product recalls
- Good manufacturing practices
- Agency inspections and remediation of inspection findings
- Responding to agency enforcement actions
- Patent term extension
We work with pharmaceutical, biologics, medical technology, diagnostics, laboratory testing, and digital health companies on a host of market access issues, including:
- Addressing critical coverage and reimbursement requirements
- Operating patient support programs
- Negotiating payor agreements
- Handling agreements with pharmacy benefit managers and GPOs
This includes addressing federal and state regulatory requirements as they relate to clients’ medical products. See “The Inflation Reduction Act & Medicare Pricing for Drugs and Biologics” for more details.
Our team includes experienced practitioners who have spent years building and operating global compliance and risk management programs from within at life sciences companies. Drawing on this experience, we help clients build programs that incorporate all the “elements of an effective compliance program” as well as the latest best practices. This involves:
- Drafting policies
- Preparing and conducting training
- Leading internal investigations
- Conducting third-party risk assessments and audits
- Advising on day-to-day business activities
- Addressing industry transparency requirements (e.g., U.S. Physician Payments Sunshine Act and related state laws)
We help clients ensure their commercial contracts and other customer relationships comply with the federal and state healthcare fraud and abuse laws, such as the Anti-Kickback Statute.
Please check out our Late Stage Drug Development Commercialization Roadmap.
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Contacts
- /en/people/t/tibbets-julie
Julie Tibbets
PartnerChair, Life Sciences Regulatory & Compliance Practice - /en/people/w/wetzel-matt
Matt Wetzel
PartnerLife Sciences & Healthcare