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Regulatory Writing & Consulting

GLOBAL offers the highest quality regulatory consulting and writing services, specializing in complex biologics, drugs, medical devices, IVDs, & combination products. 

Meet the Regulatory Affairs Leadership Team

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Tracy Janus, MSC

Sr VP, Regulatory Affairs & CMC

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Location: Bucks Country, Pennsylvania


Favorite Biotech or Med Device Nerd Topic: Gene therapy


Biggest Thrill/Adventure Completed: My first Ragnar Trail Relay event


Most Important Bucket List Item: See the Northern Lights

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Sharon McFadden, DVM

VP, Clinical Operations & Medical Affairs

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Location: Oregon


Favorite Biotech or Med Device Nerd Topic: Pivot tables of data


Biggest Thrill/Adventure

completed: Ironman Triathlon


Most Important Bucket List Item: Hiking trip to Tasmania

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Thomas Stone, JD

Senior Director 

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Location: Colorado Springs, CO


Favorite Biotech or Med Device Nerd Topic: EU MDR; FDA and Agency Law; Opioid Crisis; Bioethics


Biggest Thrill/Adventure Completed: Obtaining a favorable verdict on all counts in my first high stakes District Court Trial


Most Important Bucket List Item: Travel to Greece and Rome

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Sarra De Valence, PhD

Associate Director

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Location: Oakland, CA


Favorite Biotech or Med Device Nerd Topic: Data analysis


Biggest Thrill/Adventure Completed: In Hawaii, jumping from my kayak into the water in the middle of a large pod of dolphins


Most Important Bucket List Item: Ride the Great Divide

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