Camargo Pharmaceutical Services
|Camargo Pharmaceutical 505(b)(2) Services|
|Slogan||The Global 505(b)(2) Experts|
|Headquarters||9825 Kenwood Road, Suite 203, Cincinnati, OH 45242|
|Key people|| Kenneth V. Phelps, President and CEO
Ruth E. Stevens, Ph.D., MBA, Chief Scientific Officer, EVP
Jim Beach, Chief Operating Officer
Carter Gaither, Chief Financial Officer
Gary K. Barnette, Ph.D., Senior VP, Scientific and Regulatory Affairs
Lynn Gold, Ph.D., VP, Scientific and Regulatory Affairs
Marc Wiles, Ph.D., VP, Scientific and Regulatory Affairs
Stacy Schnieber, MA HR, PHR, Director, Human Resources
Nigel Fernandes, Executive Director of Business Development
Mary Liz James, Executive Director of Business Development
Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes. By assessing the scientific, medical, regulatory and commercial viability of product development opportunities, Camargo systematically builds and executes complete development plans that align with business strategies and that ensure FDA buy-in every step of the way. Routinely holding three to six pre-IND meetings a month, Camargo has guided more than 200 FDA approvals and works with product developers across more than 25 countries.
Identify Viable Product Opportunity Feasibility, Pre-IND/integrated Development Plan, Product Ideation.
Develop Viable Products Nonclinical testing, Chemistry, manufacturing and controls (CMC), Clinical studies, Phases I-IV.
Regulatory Strategy FDA meetings and submissions, Additional regulatory services, Complex Generics