HartmannWillner LLC is a FDA regulatory affairs consulting firm that offers strategic and technical advice, IND and BLA writing, and GMP compliance inspections and mock FDA audits to the biologics, biotechnology, biosimilar, and biologics/device combination products industries. We offer publishing of eCTD submissions, eMDRs, and SPL generation for the pharmaceutical, biotechnology, and medical device industries. Experienced expert witness services are provided having testified on the FDA regulatory process and GMP compliance matters. Our background in the interpretation and application of FDA laws, regulations, and Guidance gives us a unique strength in understanding and explaining these complex requirements in plain terms. Our experience both in the FDA and industry allows us to understand the needs of our clients and the FDA enabling collaborative relationships.
View Top Employees from HARTMANN WILLNER, LLCWebsite | http://www.hartmannwillner.com/ |
Revenue | $608000 |
Employees | 3 (3 on RocketReach) |
Address | 8805 Tamiami Trl N, Naples, Florida 34108, US |
Phone | (239) 734-3007 |
Technologies |
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Industry | Biotechnology Research, Drug Stores & Pharmacies, Retail |
Competitors | Aariya Regulatory Services, Pharmaceutical Development Group, Regulatory Interlinx Inc, Universal Regulatory, Inc, Velesco Pharmaceutical Services |
SIC | SIC Code 283 Companies, SIC Code 28 Companies |
NAICS | NAICS Code 32 Companies, NAICS Code 32541 Companies, NAICS Code 325 Companies, NAICS Code 3254 Companies |
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The HARTMANN WILLNER, LLC annual revenue was $608000 in 2024.
Suzanne Sensabaugh is the President and Principal Consultant of HARTMANN WILLNER, LLC.
3 people are employed at HARTMANN WILLNER, LLC.
HARTMANN WILLNER, LLC is based in Naples, Florida.
The NAICS codes for HARTMANN WILLNER, LLC are [32, 32541, 325, 3254].
The SIC codes for HARTMANN WILLNER, LLC are [283, 28].