Hartmann Willner LLC is a boutique FDA biologics consulting group based in Washington, DC. With over 30 years of FDA regulatory experience, they specialize in providing expert guidance on biologics, biosimilars, biotechnology, and biologic device combination products. Their unique strength lies in their ex-FDA knowledge and insight gained from developing biologics, allowing them to understand complex regulatory requirements and find solutions to regulatory hurdles.
As a team, Hartmann Willner works closely with their clients and FDA colleagues to ensure timely and FDA-compliant submissions, helping their clients achieve their commercial goals. They offer a personalized approach, providing budget and action plans specific to each client's needs, and their expertise has been instrumental in the development of over 120 FDA regulated products since 2009.
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