FDA Regulatory Consulting Firm Focused on Results

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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

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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.

The FDA recently released this guidance to detail the agency’s recommendations for the design and evaluation of comparative analytical studies to demonstrate that a proposed therapeutic protein product is biosimilar to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act).

Furthermore, the guidance includes recommendations for sponsors concerning scientific and technical information for the chemistry, manufacturing, and controls (CMC) areas of the marketing application for a proposed product…

The purpose of this guidance is to aid sponsors by showcasing that a proposed therapeutic protein product can be exchanged with a reference product for the intentions of submitting a marketing application or supplement under section 351 (k) of the Public Health Service Act (PHS Act).

On September 4, 2018, FDA held a public hearing to hear comments from different stakeholders on FDA’s Biosimilar Action Plan (BAP).

 

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