DataRevive Services / 咨询服务

我们是一家监管咨询公司,帮助制药和生物技术公司在药物开发过程中对美国IND,BLA和NDA进行申报。 我们专注于小分子和生物产品监管事务。我们在CMC (chemistry, manufacturing, controls),非临床,临床药理学和临床领域拥有专业知识。 我们的专家都具有至少18年以上的US药物研发和法规申报经验。

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