HartmannWillner LLC

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About US: Suzanne's consulting practice focuses on regulatory affairs, drug development, and compliance matters involving the FDA. She provides professional advice to clients on biologics, biotechnology, biosimilars, and biologic/device combination products. Her experience includes INDs; BLAs; NDAs, including 505(b)(2); clinical trials; CMC; comparability; pharmacology/toxicology; and Orphan Drug designations. Suzanne has provided expert advice for many compliance issues, including GMP inspections, 483 and warning letter responses, and conducts cGMP inspections. Expert witness for FDA cGMP compliance issues.
Web Site: http://www.hartmannwillner.com
Address: 410 O St SW #404
Washington, DC 20024
United States
Phone: +1 202 484 1362
Email: smsensabaugh@hartmannwillner.com
Contact: Suzanne Sensabaugh
President and Principal Consultant
Business Type: Consulting
Authorized Representative
Quality Assurance
Audit/Inspections