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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
Market Assessment
Regulatory Strategy
Complex Generics
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
Dan Duffy
Chief Executive Officer
Biography
Kenneth V. Phelps
President and Founder
Biography
Ruth E. Stevens, Ph.D., MBA
Chief Scientific Officer, EVP
Biography
Carter Gaither
Chief Financial Officer
Biography
Reeves McGee
VP of Commercial Solutions
Biography
Thomas Henning
VP of Marketing
Biography
Stacy Schnieber, MA HR, PHR
VP of People and Culture
Biography
Scott T Cain, MPH, PhD
VP Regulatory Science
Biography
Jennie Orr
Vice President of Product Strategy
Biography
Nigel Fernandes
Executive Director of Business Development
Biography
Mary Liz James
Executive Director of Business Development
Biography
