FDA Regulatory Consulting Firm Focused on Results

Understand complex FDA requirements in plain terms.
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Welcome to HartmannWillner

We’re here to help you file your submission on time and in FDA compliance.

Suzanne M. Sensabaugh

Biologics Consultant

Suzanne M. Sensabaugh is President and Principal Consultant of Hartmann Willner, where she is a regulatory affairs consultant who provides professional advice to clients.

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.

Expertise

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 advanced the development of over 130 biologics and biosimilars.

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

Get FDA regulatory insights delivered to you inbox.

The FDA released this guidance to help sponsors and applicants using real-world data (RWD) to produce real-world evidence (RWE) for a regulatory submission.

This encompasses submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license application (BLAs) that have RWE to prove their safety and effectiveness in relation to regulatory decisions.

The FDA recently released a final guidance concerning postmarketing safety reporting for combination products.The FDA recently released a final guidance concerning postmarketing safety reporting for combination products.    

Specifically, a combination product is comprised of any combination of a drug, device, and biological product. Each component is considered to be a constituent part of the combination product. These combination products are reviewed and regulated by the assigned Agency center that has primary jurisdiction.

 

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HartmannWillner update to the eCTD Mandate

The intention of this guidance was to help sponsors in assessing reproductive toxicity (mostly for the effects on embryo-fetal development (EFD)) for oncology pharmaceuticals and outline recommendations for product labeling

on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus. Evaluation of EFD toxicity for certain types of pharmaceuticals and their intended populations are discussed in the guidance.

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