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Phase II Services - Regulatory Submissions


BCI has extensive experience preparing all types of major regulatory submissions, including complex multinational submissions. BCI can provide review of each submission for verification of compliance with applicable guidelines and for potential refusal-to-file issues. BCI can provide these services as part of the client’s internal project team or as a stand alone service. With offices in North America and Asia, and offices opening soon in Europe, BCI global regulatory affairs team is an experienced and skilled in the coordination and preparation of global regulatory submissions. These global regulatory submissions include:

  • Abbreviated new drug applications (ANDA)
  • Biologics license applications (BLA)
  • Clinical trial authorization/application/exemptions (CTA/CTX)
  • Clinical trial notifications (CTN)
  • Common technical document (CTD)
  • Drug master files (DMF)
  • Fast track applications
  • Investigational drug exemptions (IDE)
  • Investigational new drug applications (IND)
  • Marketing authorization applications (MAA)
  • New drug applications (NDA)
  • New drug submissions (NDS)
  • Orphan drug applications (ODA)
  • Premarket approvals (PMA)/510(k)s