Welcome

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, device, and in vitro diagnostics 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. 

Partnering

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