Regulatory Strategy Consulting

DataRevive specializes in regulatory strategy. Our experts will lead you to the right regulatory pathway and then apply their highly specialized expertise to help you reach approval effectively and efficiently.

We guide clients to define robust regulatory and clinical development plans with a focus on streamlining the time it takes to move through the phases from IND to NDA and BLA. Tap the experience within our team of former FDA CMC and clinical professionals for:

  • Regulatory Strategy for Product Development
  • Expedited Pathway Guidance: Fast Track, Breakthrough Therapy, Orphan Drug Designation (ODD), and More
  • IND, NDA, and BLA Dossier Writing, including, CMC, Preclinical & Clinical
  • Dossier Review for IND, NDA & BLA
  • Face-to-Face Representation at FDA Meetings
  • eCTD Submission
  • Investor Due Diligence

No matter the kinds of products you have – classic IgGs, antibody-drug conjugates, nanobodies, Fc fusion proteins, bispecific antibodies, PEGylated proteins, antibody-enzyme fusions, enzyme products, cytokines, radiolabeled antibodies, small molecules, or NCEs – we have the expertise to optimize your regulatory strategy from end to end.

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