FDA Regulatory Consulting Firm Focused on Results

Understand complex FDA requirements in plain terms. See Our Services

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

Get FDA regulatory insights delivered to you inbox.

Adverse events (AE) occur when any untoward medical situations arise and can be associated with the use of a drug.

As such, when an AE occurs, companies, institutional review boards (IRBs), data and safety monitoring boards (DSMB), patients, investigators, regulatory agencies and research subjects require prompt notification.

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HartmannWillner update to the eCTD Mandate

FDA releases Q&A guidance after confusion surrounding S9A Nonclinical Evaluation for anticancer pharmaceuticals guidance.

The S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Guidance (ICH S9) has resulted in confusion and challenges amongst its users…

The FDA guidance document Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 explains the changes, but let’s review the important items.

Quick introduction

The Biosimilar User Fee Act of 2012 (BsUFA I) added sections to the FD&C Act, authorizing FDA to collect user fees for a 5-year period…

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