Meet Your Team
We’re here to help you file your submission on time and in FDA compliance.
Suzanne M. Sensabaugh
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
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.
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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Biological products have historically been approved under two laws: The Public Health Service Act (PHS Act) through a Biologics License Application (BLA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) through a New Drug Application (NDA). Biological products are “licensed” under the PHS Act and “approved” under the FD&C Act.
Biological products are “licensed” under the PHS Act and “approved” under the FD&C Act. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) mandated that biological products…
There’s been some buzzing about the FDA instituting a new review system called Knowledge-aided Assessment and Structured Application (KASA)
In September 2018, the FDA met with the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee to explore the positive aspects of adopting this system.
HW was at FDA for the Part 15 public hearing to hear comments from different stakeholders on FDA’s Biosimilar Action Plan (BAP)
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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