FDA Regulatory Consulting Firm Focused on Results

Understand complex FDA requirements in plain terms.
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We’re here to help you file your submission on time and in FDA compliance.

The HartmannWillner Difference

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.


You’ll receive over 30 years of FDA regulatory experience focused on biologics, biosimilars, biotechnology, and biologic device combination products to advise you every step of the way. Since 2009, we have assisted in the development of over 120 FDA regulated products.

You Get Us

When you hire us, you’ll work with us. Our product won’t be transferred to a regulatory consultant with less experience.

We Speak Your Language

You won’t have to go through the business development maze to speak to someone who understands your complex regulatory and scientific issues. We’ll work with you in putting in place a budget and plan of action specific to these needs.

FDA Regulatory Insights

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FDA is making biological products more easily distinguishable

The US Food and Drug Administration (FDA) recently released the final version of the guidance document about nonproprietary naming…

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The FDA and Scientific Experts Discuss Infectious Disease Risk

The FDA and scientific experts met to discuss infectious disease risk to the donor population, ways to prevent, and be prepared.

FDA released a guidance on interchangeability earlier this year, is your company ready?

In the last decade, there has been an emergence of cutting-edge technologies used to discover or create…

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