FDA LAW BOSTON is a specialized law firm providing strategic and legal counsel to non-profit foundations, hospitals, and FDA-regulated industry. Led by Allan M. Green, MD, PhD, JD, the firm stands out through its unique integration of legal, clinical medicine, and scientific research expertise, focusing on the complex challenges of translational research and regulatory compliance.
The firm leverages deep life science industry knowledge to offer clients informed strategic planning and due diligence assessments, aiding in capital investment and technology evaluation. It is particularly focused on assisting stakeholders in moving new scientific findings from research to clinical application, providing clarity and guidance through every stage of the FDA regulatory process.
Services Offered
- FDA regulatory support
- Strategic planning advice
- Independent due diligence assessment of technology and program strategy
- Assistance with obtaining FDA approval for manufacturing, investigation, and marketing
- Resolution of administrative issues pre- and post-approval
- Guidance on IND and IDE submission requirements
- Planning of human clinical trials for marketing clearance
- Contracting, conducting, and interpreting clinical trial results
- Optimization of marketing approval terms and conditions
- Addressing good clinical practice (GCP) and good manufacturing practice (GMP) compliance problems
- Preparation of life sciences technology licensing agreements
- Drafting and negotiation of R&D agreements
- Third-party assessments of plans, timelines, and practices for investors and industry clients
The firm serves clients nationally from its base in Cambridge, MA, and is equipped to handle complex regulatory and strategic matters across the biomedical and medical device sectors.
