DataRevive Services

We are a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of US IND, BLA, and NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs. We have expertise in CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. Our lead consultants have worked in FDA or industry for more than 18 years with extensive experience in drug discovery and development.

CMC

  • CMC design including the post approval comparability study, results analysis, package writing and submission to FDA
  • GMP audit for both small molecules and biologic products especially for aseptic processing
  • Pre-approval mock inspections
  • Entire CMC regulatory dossier writing to support the IND, BLA/NDAs

Nonclinical

  • Nonclinical GLP study design, protocol review and study monitoring
  • PK/PD modeling
  • Starting dose justification

Clinical

  • Clinical study design (Phase I, II, III), protocol writing, data analysis, study report preparation
  • Clinical site monitoring (CRA services)
  • Statistical analysis for clinical study results
  • Clinical sample size calculation
  • Pharmacovigilance

Regulatory

  • PIND meeting request, briefing package preparation
  • FDA meetings: PIND, EOP2, EOP3, Biosimilar
  • IND/BLA dossier writing in CTD format to support global regulatory filing
  • eCTD filing
  • US agent for foreign companies
  • IND, NDA and BLA maintenance
  • Professional translation service to generate ready to submit dossiers
Blackboard showing steps of Pre-IND meeting