HartmannWillner

HartmannWillner is a leading biotechnology regulatory affairs consulting firm dedicated to providing strategic and technical guidance to the biologics, biotechnology, biosimilar, and biologics/device combination products industries. Located in Washington, D.C., with a primary address at 100 M Street SE, Suite 600, Washington, D.C. 20003, US, HartmannWillner specializes in FDA regulatory affairs consulting, including expert IND and BLA writing, comprehensive GMP compliance inspections, and realistic mock FDA audits. The firm's expertise extends to FDA electronic publishing, supporting eCTD submissions, eMDRs, and SPL generation for clients in the pharmaceutical, biotechnology, and medical device sectors.

HartmannWillner's deep understanding of FDA laws, regulations, and Guidance, combined with extensive experience both within the FDA and in industry, enables the firm to offer clear and practical advice. The team’s collaborative approach fosters strong relationships with clients and the FDA, ensuring smooth and efficient regulatory processes. With a focus on delivering exceptional service and building a track record of success, HartmannWillner is a trusted partner for companies navigating the complexities of the biotechnology landscape.

Building on a foundation of regulatory expertise, HartmannWillner also provides experienced expert witness services, bringing a unique perspective on the FDA regulatory process and GMP compliance matters. We invite you to create a customized and exclusive company showcase and product listing on our platform, allowing HartmannWillner to further highlight its industry leadership and value proposition.