Life Sciences Transactions & Healthcare Regulations
Navigating Complexity. Accelerating Growth.
Experienced counsel for transactions, compliance, and global operations in life sciences and healthcare.
Core Services
We guide clients through the entire product lifecycle — from early-stage discovery and clinical development to manufacturing, commercialization, and post-market compliance.
Strategic Transactions & Collaborations
We advise on technology licensing, R&D collaborations, and commercialization agreements with commercial, university, and nonprofit partners. We also structure healthcare joint ventures and other strategic transactions.
Clinical Development
We support many aspects of clinical development, including drafting and negotiating clinical trial agreements (CTAs), informed consent forms (ICFs), CDMO/CDMO quality agreements, and related operational contracts such as CDAs, MTAs, SRAs, MSAs, and DLAs.
Manufacturing & Supply Chain
Our services cover pre- and post-commercial product launch activities, including GMP manufacturing agreements, quality agreements, and arrangements for sales, marketing, and distribution. We also review promotional materials to ensure compliance with applicable regulations.
Regulatory Compliance
We offer comprehensive regulatory counseling on FDA and EMA matters for drugs, devices, biologics, diagnostics, and nutraceuticals). Our support includes submissions and approvals (510(k), NDA, BLA), as well as guidance on HIPAA/HITECH, the Anti-Kickback Statute, Stark Law, and FCPA/UK Bribery Act.
Global Operations
We assist clients with cross-border transactions, the development of international compliance programs, and risk management for multinational operations, including matters involving U.S. and international data privacy.
Meet The Life Sciences Transactions & Healthcare Regulations Team
Our attorneys have sat in the C-suite and led legal strategy inside some of the world’s top biotech, pharma, medical device, and healthcare organizations. That firsthand experience is our edge — giving us the perspective to deliver practical, business-minded counsel that’s precisely tuned to the demands of this complex and highly-regulated industry.
Michèle Linde
Practice Group Leader
Also practicing in this area
Why Clients Choose OGC
“We’re incredibly grateful for the legal support we receive from Outside GC. Our OGC works closely with our business and scientific teams, reviewing a wide range of vendor contracts. Their industry experience is critical, enabling a skillful assessment of our needs and risk tolerance. They are also very responsive to our requests for support, which is not always the case with outside counsel. An all-around great partner!”
“Working with OGC has been invaluable to Foresight Imaging. Our attorney is exceptionally responsive—turning around critical documents and contract reviews with impressive speed and precision. Her practical, detail-oriented approach ensures our agreements with healthcare partners are not only compliant but also strategically aligned with our business goals. She delivers timely, actionable advice that protects our interests and helps move the company forward with confidence. Her support has become a trusted foundation of our success.”
“OGC has been a valued partner to BioCorRx for many years. They provide quick, accurate, and practical legal support that helps us advance our mission at rates far more reasonable than other healthcare law firms. Their work, from contract preparation and review to regulatory and general business advice, has helped us grow with confidence in a highly regulated industry.”
“As a business development executive working with innovative biotech clients spanning the globe, I have worked with a number of large global law firms. My OGC attorney rivals these firms in terms of experience, and I value the quality of his work, responsiveness and ability to provide practical advice in a highly technical and regulated industry.”
Insights In Action
HIPAA Changes Coming in 2026
HIPAA Changes Coming in 2026 https://outsidegc.com/wp-content/uploads/2025/12/Doctor-hand-holding-a-jigsaw-puzzle-with-HIPAA-word.-Concept-Healthy.-1056607472_1258x838-copy-600x320-c-default.webp 600 320 ValUpqode https://secure.gravatar.com/avatar/70f75c56da1e1c1410f23a9bfd7fe63052e789f7642caffef985fa2c8aef938c?s=96&d=mm&r=g
What’s Next for Biotech Regulation in 2026
What’s Next for Biotech Regulation in 2026 https://outsidegc.com/wp-content/uploads/2026/01/OGC-FDA-CMS-and-data-privacy-600x320-c-default.webp 600 320 ValUpqode https://secure.gravatar.com/avatar/70f75c56da1e1c1410f23a9bfd7fe63052e789f7642caffef985fa2c8aef938c?s=96&d=mm&r=g
Working in the grey: FDA, CMS and data privacy
Working in the grey: FDA, CMS and data privacy https://outsidegc.com/wp-content/uploads/2025/05/OGC-FDA-CMS-and-data-privacy.webp 1200 628 Carrie https://secure.gravatar.com/avatar/61e4278020699b4ee1d8a51fb564b545b74eccf84cf91c8f31a1df28c306b858?s=96&d=mm&r=g
Negotiating Health Insurance Contracts, Part 3: Proven Strategies for Providers and Hospitals
Negotiating Health Insurance Contracts, Part 3: Proven Strategies for Providers and Hospitals https://outsidegc.com/wp-content/uploads/2025/03/OGC-Negotiating-Health-Insurance-Contracts.png 1200 628 Lynn Kuzneski https://secure.gravatar.com/avatar/e7450be31e0ae50d63cc6a150e032104cef3e205800828abf74ee542ed996001?s=96&d=mm&r=g
Negotiating Health Insurance Contracts, Part 2: Critical Provisions to Watch
Negotiating Health Insurance Contracts, Part 2: Critical Provisions to Watch https://outsidegc.com/wp-content/uploads/2025/02/OGC-Attorney-Thought-Leadership-Holly-Little-2.png 1200 628 Lynn Kuzneski https://secure.gravatar.com/avatar/e7450be31e0ae50d63cc6a150e032104cef3e205800828abf74ee542ed996001?s=96&d=mm&r=g
Making the Case for Health Insurance Contract Negotiations
Making the Case for Health Insurance Contract Negotiations https://outsidegc.com/wp-content/uploads/2025/02/OGC-Attorney-Thought-Leadership-Holly-Little-2.png 1200 628 Lynn Kuzneski https://secure.gravatar.com/avatar/e7450be31e0ae50d63cc6a150e032104cef3e205800828abf74ee542ed996001?s=96&d=mm&r=gMoving Business Forward, Together.
From routine matters to complex transactions, OGC is your trusted partner for what’s next.