505(b)(2): Is it for you?
A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method gains approval for new drugs in a fraction of the time and cost required by traditional paths.
Camargo's expertise in drug approval and thorough understanding of the FDA and its evolving standards will put your product on the fast-track to market. Specializing in the 505(b)(2) pathway globally, our team executes a spectrum of small and large molecule development programs. We take you from discovery to post-approval marketing, with a full range of services in between for pharmaceutical and biotech development teams of all sizes.
Camargo can help you reach cost-effective solutions, increase speed-to-market time and aid you in maintaining regulatory compliance. With Camargo is by your side— you couldn't ask for a better companion.