Meet the Team
Our mission is to provide premier Regulatory Affairs consulting services and to continually partner with our clients to fulfill their business goals. We take pride in committing to excellence, integrity, accountability, and respect.
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Mark Ammann, Pharm D
PRESIDENT & CO-FOUNDER
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Dawn Chitty, MS
SENIOR VICE PRESIDENT & CO-FOUNDER
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Mara Holinger, PhD, RAC
SENIOR VICE PRESIDENT & CO-FOUNDER
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Kevin Hennegan, MA
HEAD OF ADVANCED THERAPIES
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Sarah Donaldson
PRINCIPAL REGULATORY STRATEGIST
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Nitya Durvasula, MS
PROJECT MANAGER & CMC SPECIALIST
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Anita Fereshetian, MS, RPh
PRINCIPAL REGULATORY STRATEGIST
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Jennifer Harmon
ASSOCIATE DIRECTOR, REGULATORY PUBLISHING
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Michelle McKern, PhD
PRINCIPAL REGULATORY STRATEGIST
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Toni Marie Nearing
PRINCIPAL REGULATORY STRATEGIST
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Alexis Northcutt, PhD, RAC
REGULATORY STRATEGIST
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Kiley Prilliman, PhD
SENIOR MEDICAL WRITER
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Ellen Truitt, RAC
REGULATORY STRATEGIST
Speak to our Regulatory Experts
Discover how our expert team can support your regulatory needs and guide you to your next milestone. Partner with us to navigate complex regulations and achieve your business goals with confidence and efficiency.