Biotechnology & Life Sciences

The Biotechnology & Life Sciences Practice Group is a core component of DBL Law. Our attorneys provide sophisticated, multidisciplinary counsel to innovative companies, research institutions, investors, and industry partners across Ohio, Kentucky, and Indiana, helping them navigate a rapidly evolving scientific and regulatory landscape.

Our team combines deep industry knowledge with practical, business-focused advice designed to support growth, manage risk, and move new technologies from concept to market.

Our Services Include:

• Start-Up, Formation, and Structuring: We assist life sciences entrepreneurs, spinouts, and emerging companies with entity selection, ownership structuring, governance, and foundational documents that support future investment and scalability.

• Research, Collaboration, and Technology Transfer Agreements: We draft and negotiate sponsored research agreements, collaboration agreements, material transfer agreements, and licensing arrangements between companies, universities, health systems, and other research partners.

• Regulatory Strategy and Compliance: We advise on FDA, EMA, and related federal and state regulatory frameworks, including product classification, pre-clinical strategy, IND/IDE submissions, labeling, marketing, and post-market obligations.

• Clinical Trials and Human Subjects Research: We support clinical trial design and documentation, site and investigator agreements, informed consent, IRB issues, and compliance with GCP and human subjects protection requirements.

• Intellectual Property and Licensing: Working closely with IP counsel, we help clients protect, license, and monetize their innovations through patents, trade secrets, and know-how, as well as structure licensing and royalty arrangements that align with long-term business goals.

• Capital Raising and Strategic Transactions: We guide clients through seed and venture financings, strategic partnerships, joint ventures, mergers and acquisitions, and exit transactions, providing counsel from initial term sheets through closing and integration.

• Manufacturing, Supply, and Commercialization: We negotiate manufacturing, supply, distribution, and commercialization agreements, ensuring quality, compliance, and clear allocation of risk as products move into the market.

• Compliance, Risk Management, and Disputes: We assist with day-to-day compliance, internal investigations, government inquiries, and litigation arising out of regulatory actions, contracts, or other operational issues.

Our Clients:

We represent a broad spectrum of life sciences stakeholders, including biotechnology and pharmaceutical companies, medical device manufacturers, digital health and diagnostics companies, academic medical centers, research institutions, health systems, and investors. Our understanding of the scientific, regulatory, and commercial drivers of the industry allows us to tailor our advice to the specific needs and growth stage of each client.

Collaborative Approach:

We work closely with colleagues across DBL Law—including Health Care, Business & Transactional, Government Advocacy & Economic Development, Employment & Labor, Real Estate, and Litigation—to deliver integrated strategies that support the full lifecycle of a life sciences business. We also coordinate with clients’ other trusted advisors, such as IP counsel, financial advisors, consultants, and technical experts, to ensure alignment across scientific, legal, and business objectives.

Why Choose DBL Law?

• Industry-Focused Team: Our attorneys have extensive experience at the highest levels of the biotechnology and life sciences sectors.
• Deep Regulatory Insight: We understand the complex regulatory frameworks that govern research, development, clinical trials, and commercialization.
• Business-Minded Counsel: We focus on practical, solutions-oriented advice that advances your scientific and commercial goals.
• Comprehensive Services: From formation and funding through clinical development, approval, and exit, we support the full product and company lifecycle.
• Commitment to Innovation and the Region: We are deeply invested in the growth of the life sciences ecosystem in Ohio, Kentucky, and Indiana and in the success of the organizations driving that growth.

Contact DBL Law today to learn how our Biotechnology & Life Sciences Practice Group can help you move your research forward, bring new products to market, and achieve your strategic objectives.