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.

Here’s Your Opportunity To Be Heard

The Food and Drug Administration (FDA) has established a public docket so that anyone can share information, comments, and ideas on any matters related to the use of their technical specifications or technical specification guidance.

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HartmannWillner update to the eCTD Mandate

The FDA had a mandate for submitting in eCTD format Drug Master Files (DMFs) (other than Type III – packaging material). Luckily for some, there was a reprieve as the FDA extended that date another year until 05 May 2019..

That said, there are still other submissions types that now need to be submitted in eCTD.

Time is money, and to help you save both time and money the FDA recently released a revised version of their Guidance for Industry on Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or Applicants (November 2015).

Here are some of the major revisions to the document.

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