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WHAT IS 505(b)(2)?
SERVICES
Identify Products
Strategic Drug Assessment
Pre-IND / Integrated Development Plan
Product Ideation
Develop Products
Nonclinical Testing
CMC Development
Clinical Studies, Phases I-IV
Regulatory Strategy
Complex Generic Services
FDA Meetings & Submissions
Additional Strategies
505(b)(2) BLOG
ABOUT
The Company
Our History
Our Experience
Leadership Team
Resources
Success Stories
White Papers
Speaking Events & Webinars
The Latest
Press and News
Events
CAREERS
CONTACT US
Leadership Team
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Leadership Team
Kenneth V. Phelps
President and CEO
Biography
Ruth E. Stevens, Ph.D., MBA
Chief Scientific Officer, EVP
Biography
Carter Gaither
Chief Financial Officer
Biography
Gary K. Barnette, Ph.D.
Senior VP, Scientific and Regulatory Affairs
Biography
Lynn Gold, Ph.D.
VP, Scientific and Regulatory Affairs
Biography
Marc Wiles, Ph.D.
VP, Scientific and Regulatory Affairs
Biography
Stacy Schnieber, MA HR, PHR
VP of People and Culture
Biography
Thomas Henning
VP of Marketing
Biography
Nigel Fernandes
Executive Director of Business Development
Biography
Mary Liz James
Executive Director of Business Development
Biography
