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Full-Service Drug Development With The 505(B)(2) Process

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.

 

For generics companies, the 505(b)(2) pathway offers a more efficient alternative to gaining approval in the United States. With numerous blockbuster drugs coming off patent, faster and cheaper development can relieve the pressure of a congested generics landscape. If you’re developing biobetter products, Camargo’s proven methods can establish safety and efficacy by applying technical design improvements and navigating you through the best regulatory approach. 

 

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.

 

Click here to learn more about our comprehensive service offerings.

 

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DRUG KENNEL

President's Blog

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