HartmannWillner, LLC
About US: Suzanne M. Sensabaugh is President and Principal Consultant of HartmannWillner, where she is a FDA regulatory affairs and cGMP consultant specializing in biologics, biosimilars, biotechnology, and biologic device combination products. She has over 30 years of experience in regulatory affairs, drug development, and FDA compliance. Her experience was gained in the FDA, pharmaceutical industry, and as a regulatory affairs consultant.

Since forming HartmannWillner in 2009, Suzanne has assisted in the development of over 130 product. During this same time period, she has conducted over 30 FDA GMP audits, to include preapproval inspections (PAI), and provided GMP compliance consulting. In addition, she has provided FDA regulatory consultant expertise to product development advisory boards, investment management and venture capital firms, and global management consulting firms. She has served as an expert witness on FDA regulatory affairs and GMP compliance matters and as a subject matter expert for NIH and OS/ASPR/BARDA Special Emphasis Panels for contract and proposal reviews for drug development funding.
Web Site: www.hw-fda.com
Address: HartmannWillner LLC
8805 Tamiami Trail North, #155
Naples, FL 34108
United States
Phone: +1 239 734 3007 
Email: smsensabaugh@hw-fda.com
Contact: Suzanne Sensabaugh 
President and Principal Consultant
Business Type: Clinical, Preclinical, CMC and Administrative Regulatory Affairs
cGMP Compliance Consulting
Investigational New Drug (IND) Applications
Biologics License Applications (BLAs)