Camargo provides you with global, end-to-end drug development capabilities specializing in the 505(b)(2) pathway. A 505(b)(2) is a new drug application (NDA) that contains full safety and effectiveness reports, but allows at least some of the information required for U.S. FDA approval to come from studies not conducted by or for the applicant. This method can help companies in India gain U.S. approval for new or reformulated drugs in a fraction of the time and cost required by traditional paths.

Camargo has the go-to experts to execute a spectrum of small and large molecule development programs for pharmaceutical and biotech teams seeking drug approval in the United States and/or who want to shift their business model to 505(b)(2).
 

If you're considering embarking on the 505(b)(2) development pathway, you need the experts at Camargo to guide you. Camargo can manage every facet of the plan throughout your development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.

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