HartmannWillner LLC can be reached at 202-484-1362 or contact us.


Let's meet at DIA in Boston to discuss the development and FDA requirements for your Biologics and Biosimilars. As co-chair for the Nonclinical and Translational Development / Early Phase Clinical Development Track, I know that there are many worthwhile presentations to see that will expand your knowledge in this critical stage of development.

Suzanne will be presenting at the 2013 AAPS NBC meeting on clinical comparability for Biosimilars. The presentation is scheduled for May 22. Contact me if you wish to receive a copy of my presentation "Current and Future Considerations Related to Clinical Comparability of  Biosimilars".

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HartmannWillner LLC is an FDA regulatory affairs consulting firm that offers strategic and technical advice and submission writing, compliance inspections and mock FDA audits, and program leadership to the biologics, biotechnology, biosimilar, and biologics/device combination products industries.

FDA consulting services

Suzanne M. Sensabaugh is President of HartmannWillner LLC. She provides consulting, liaison, project and program support to the biologics, biotechnology, biosimilar, device, and in vitro diagnostics industries on FDA regulatory matters. Suzanne's technical knowledge and executive experience allow her to provide insight that reduces uncertainty in regulatory decision making. In addition to offering independent expert advice, she also marries her expertise to novel molecules and technologies thereby providing knowledge for a lower price and generating value for emerging companies and those seeking to outsource. 

Whether yours is a virtual company seeking regulatory affairs leadership to design, draft and submit an Investigational New Drug Application (IND), Biologics License Application (BLA), or New Drug Application (NDA); an emerging company requiring assistance in the conduct of a risk assessment prior to the initiation of a Phase I First-in-Man clinical trial for a potential high-risk molecule; an established company requiring niche technical expertise; or a company preparing for a FDA inspection; you can trust HartmannWillner to develop effective solutions.

Experience you can trust

Suzanne's background in the interpretation and application of FDA laws, regulations, and guidance gives her a unique strength in understanding and explaining these complex requirements in plain terms. Her experience both in the government and industry allows her to understand the needs of her clients and the FDA enabling collaborative relationships. 


Suzanne partners with other regulatory affairs and drug development experts to provide knowledge and advice on all FDA matters.

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