HartmannWillner, LLC
About US: Navigating the FDA regulatory process can be challenging. Since 2009 we have advanced the development of over 130 products. We are a boutique FDA biologics consulting group specializing in biologics, biosimilars, biotechnology, and biologic device combination products. Our ex-FDA knowledge gives us a unique strength in understanding these complex requirements to guide your biologic to FDA approval. Our insight gained from developing biologics and gaining approval while working in the pharmaceutical industry allows us to understand regulatory issues from the other side to find solutions to regulatory hurdles. We work as a team partnering with our client and FDA colleagues to meet your commercial goals.

We also provide eCTD publishing services through the ESG.
Web Site: www.hw-fda.com
Address: HartmannWillner LLC
4851 Tamiami Trail N, Suite 200
Naples, FL 34103 
United States
Phone: +1 239 734 3007 
Email: smsensabaugh@hw-fda.com
Contact: Suzanne Sensabaugh 
President and Principal Consultant
Business Type: Consulting 
Authorized Representative 
Quality Assurance 
Audit/Inspections