FDA Regulatory Consulting Firm Focused on Results

Understand complex FDA requirements in plain terms.
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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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HartmannWillner update to the eCTD Mandate

Noun; a link from a hypertext file or document to another location or file, typically activated by clicking on a highlighted word (typically blue colored text) or an image on the screen.

There is a method to the madness and thought processes associated with the blue colored text for hyperlinks. You can read more about the history of hyperlinks and how the blue text was selected in the Hyperlink Usability: Guidelines for Usable Links (Naji, 2016).

In our previous blog post we described the user fee types for biosimilars: Biosimilar Biological Product Development (BPD) Fees, Application fees and Program fees. .

In our previous blog post we described the user fee types for biosimilars: Biosimilar Biological Product Development (BPD) Fees, Application fees and Program fees.

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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