Expertise to Support the Approval of your 505(b)(2) or Hybrid Drug Submissions
A generic molecule with a different route of administration, format, strength, or indication from the original reference product requires re-approval for market authorization, partly based on data from the original medicine, and partly on data from new clinical trials on the modified version.
Consult The Altascientist for a review of the requirements for such approval, including a case study outlining three key studies we conducted for a 505(b)(2):
Altasciences ensures a seamless process for your 505(b)(2) or Hybrid medicine submissions, with integrated manufacturing, bioanalysis and comprehensive research support services that can expedite your clinical trials.
Speak with our experts.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
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