The Law Office of Shannon O’Barr Sausville is a specialized legal practice focusing on the complex regulatory landscape of human subjects research, FDA product approval, and the broader health care industry. As a background in science, public health, and law, Ms. Sausville offers a unique, multidisciplinary approach to navigating ever-changing regulations, distinguishing her firm through deep expertise in highly technical and compliance-driven areas.
Operating as a solo practitioner, Ms. Sausville provides personalized, attentive service to each client, whether they are initiating the regulatory process for a new drug or addressing specific challenges mid-stream. Her practice is tailored to support researchers, pharmaceutical developers, health care providers, and organizations involved in clinical trials, ensuring they meet stringent requirements set by the FDA, IRBs, and other regulatory bodies.
Services Offered
- IND / IDE submissions
- FDA 483 letters
- Informed consents
- Clinical trial contracts
- HIPAA compliance
- IRB submissions
- Clinicaltrials.gov compliance
- Human subjects research compliance
- Clinical trials best practices and standard operating procedures
- Physician employment contracts
- General practice legal services
