HARTMANNWILLNER

Navigating the FDA regulatory process can be challenging. We are a boutique FDA biologics consulting group specializing in biologics, biosimilars, biotechnology, and biologic device combination products. Our ex-FDA knowledge gives us a unique strength in understanding these complex requirements to guide your biologic to FDA approval. Our insight gained from developing biologics and gaining approval while working in the pharmaceutical industry allows us to understand regulatory issues from the other side to find solutions to regulatory hurdles. We work as a team partnering with our client and FDA colleagues to meet your commercial goals... When you hire us, you'll work with us. Our product won't be transferred to a regulatory consultant with less experience.

Also known as: HartmannWillner, LLC

Primary location: Naples United States