DataRevive Experience

We are specialized in biologic and small molecule product consulting for CMC, preclinical GLP study design, protocol review to clinical study design, clinical protocol writing, data analysis, study report preparation, PK/PD modeling and simulation, clinical site monitoring, clinical pharmacovigilance, and overall regulatory strategy. No matter what kind of products you have: classic IgG, antibody drug conjugate, nanobody, Fc fusion protein, bispecific antibodies, PEGylated protein, antibody-enzyme fusion, enzyme products, cytokines, radiolabeled antibodies, small molecule 505 b(2), and NCE, as long as you can create it, we can lead you to the right regulatory pathway.

Examples of current consulting work:

  • Antibody drug conjugate IND filing package preparation
  • Biosimilar product development FDA advisory meeting preparation
  • Breakthrough product BLA filing
  • Fast track designation request package preparation
  • Orphan drug desingation request
  • Audition of the finished drug product and drug substance manufacturing facilities
  • 505 b(2) application for small molecule
  • Qualified infectious disease product development
  • Pre-approval GMP mock inspection
  • Clinical site monitoring
  • Different IND phase dossier writing and submission including: monoclonal antibody (novel and biosimilar), cell and gene therapy products, insulin and cytokine, live bacteria, and small molecules