HartmannWillner

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.