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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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.
This guidance was recently released and serves to distribute information concerning the enactment of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
This section of the law allows FDA to require particular postmarketing studies and clinical trials for prescription drugs that fall under this law and biological products affiliated with the Public Health Service (PHS) Act of section 351.
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.
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