FDA Regulatory Consulting Firm Focused on Results

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Meet Your Team

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.

Mary L. Waters

eCTD Publishing Services

Mary Waters is a Senior Consultant for HartmannWillner, providing technical advice and expertise in eCTDs, publishing services, ICH and FDA regulatory requirements.

Nitisha Pyndiah, PhD

Biologics Consultant

Nitisha Pyndiah, PhD is a Consultant for HartmannWillner where she provides Biologics Consulting Services, specializing in CMC, bioassays, and immunogenicity risk assessments.

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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Welcome to part three of this mini-series revolving around the recently-released 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.

In the previous two posts, we provided background relevant to this update…

To follow up to our previous part 1 about the analytical data required to demonstrate interchangeability, let’s look into clinical studies required.

What clinical studies are required to demonstrate interchangeability?

Regenerative Medicine Advanced Therapy Designation: Regulatory Shortcuts for Market Approval

Near the end of 2016, the United States Congress enacted the 21st Century Cures Act to expedite the development and review of biologics that address unmet medical needs.

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