Welcome to HartmannWillner
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.
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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Recently, the FDA released the guidance “Manufacturing Consideration for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency.”
This guidance is meant to supplement the recommendations to drug and biological product manufacturers stated in the FDA’s “Good Manufacturing Practice Considerations for Responding to COVD-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry” that was published in June 2020
In August, the FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized COVID-19 patients. Since then, the FDA has released a revised EUA.
The COVID-19 convalescent plasma may be used under an EUA associated with the proper authorization or under an investigational new drug application (IND). Recently, the FDA released the “Investigational COVID-19 Convalescent Plasma” guidance.
The intention of this guidance is to clarify FDA expectations related to facility information that must be included in original new drug applications (NDA), abbreviated new drug applications (ANDA), original biologics license applications (BLA), controls supplements (CMC), and resubmissions related to these categories.
Completion of Form FDA 356h satisfies the requirement for applicants to submit an application form. This form is a summary of administrative information and details manufacturing, packaging, and control site information for the drug substance and drug product facilities affiliated with the application.
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