Regulatory Writing & Consulting
GLOBAL offers the highest quality regulatory consulting and writing services, specializing in complex biologics, drugs, medical devices, IVDs, & combination products.
What kind of product can we support today?
Meet the Regulatory Affairs Leadership Team
Tracy Janus, MSC
Sr VP, Regulatory Affairs & CMC
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
Sharon McFadden, DVM
VP, Clinical Operations & Medical Affairs
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
Thomas Stone, JD
Senior Director
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
Sarra De Valence, PhD
Associate Director
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