FDA & Life Sciences

Hall Render helps life sciences companies bring safe, effective products to market—and keep them there. Our FDA team advises pharmaceutical, medical device, biotechnology, diagnostics and digital health innovators across the full product lifecycle: concept, clinical research, authorization, commercialization and post-market compliance.

We counsel pharmaceutical, biotechnology, medical device and diagnostic companies—as well as health systems and research organizations—on FDA compliance across the product lifecycle. From product development and clinical trials to marketing, labeling and post-market obligations, our attorneys guide clients through the regulatory requirements that govern safety, efficacy and quality.

Our team also advises on clinical research, helping organizations structure studies, negotiate agreements and ensure compliance with federal and state laws, including those related to human subject protections, billing and financial relationships. We partner with clients to align research goals with regulatory expectations while reducing risk and preserving the integrity of the research enterprise.

By combining deep regulatory knowledge with practical health care industry insight, we provide solutions that support innovation while safeguarding compliance. Whether advancing groundbreaking therapies or conducting clinical trials, our Life Sciences services enable clients to bring new treatments to market responsibly and effectively.

What We Do

• Accelerate your path to market. We plan regulatory strategy and guide submissions—Investigational New Drug and Investigational Device Exemption applications, Premarket Notification 510(k) submissions, Premarket Approval applications, De Novo classification requests, 513(g) requests, product classification requests and FDA Pre-Submission meetings—so your dossier is complete and persuasive.
• Strengthen clinical research. We support protocol and Clinical Trial Agreement review, Institutional Review Board governance, Good Clinical Practice, Common Rule compliance and research-integrity counseling for sponsors and investigators.
• Prepare for FDA scrutiny. We lead inspection-readiness efforts (mock interviews, standard operating procedure and records reviews, corrective and preventive action planning, team training), help navigate inspections and draft responses to FDA Form 483 observations and Warning Letters through corrective action and follow-up.
• Promote responsibly. We review advertising and labeling to align with FDA and Federal Trade Commission requirements and handle competitor challenges before the National Advertising Division.
• Advise on emerging technology. We evaluate software as a medical device, AI/ML-enabled tools, 3D-printed devices and evolving frameworks for diagnostics and laboratory-developed tests.