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Developing Strategies
to Address Challenging Regulatory Issues

Abstract Structure

I help pharmaceutical manufacturers bring their products to market quickly and efficiently to improve patients' access to the medicines they need.

-Lisa, Principal

Scientist with Test Tubes
Our Services
Lisa’s experience working at the FDA and with the trade association has provided her with a unique perspective on how industry interprets the Agency and how that may lead to issues in industry’s response to Agency requests or meeting FDA requirements. As a result, Lisa can provide insight and guidance on scientific, regulatory, regulatory- policy, and user fee issues.
Scientific Issues
Meeting FDA standards on nitrosamines, inactive ingredients, or dissolution
Regulatory and
PoIicy Issues

Responding to complete response letters (CRLs) or information requests (IRs); understanding complexities associated with drug-device combination products; controlled correspondence, Inactive Ingredients Database, policy, and procedures arising from implementation of the user fee commitments
User Fee Issues
Guidance on understanding which fees are due and when; handling dispute resolutions; or optimizing user fee liabilities across portfolios
Lisa earned a Bachelor of Science in Pharmacy from the Massachusetts College of Pharmacy and began her career working in retail pharmacy when generic drugs were just hitting the commercial market. She witnessed firsthand the impact affordable drugs had on patients – those who needed to stretch their medications by cutting tablets could now afford the full course of their treatments, and some could afford prescription drugs for the first time. These lessons were reinforced throughout her career at Johns Hopkins, AmerisourceBergen, and Suburban Hospital.

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