Camargo Pharmaceutical Services

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https://camargopharma.com
Camargo Pharmaceutical 505(b)(2) Services
Type Private
Industry Pharmaceutical Consulting
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

History

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.

Services

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

Top 5 Recent News Headlines

V ClinBio Partners with Camargo for Strategic 505(b)(2) Development of Transformative Prodrug Technology Platform at PRNewswire

Aequus and Camargo Prepare for Meeting with FDA to Advance Anti-Nausea Patch at MarketWired

Camargo CEO Meeting with Leading Companies in Japan, Korea, Taiwan, and India at PR Newswire

Veru Announces Tamsulosin DRS Bioequivalence Clinical Trial Results at Globe Newswire

Callitas Announces Positive FDA Response to Extrinsa Pre-IND Submission at AccessWire

References

https://camargopharma.com

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