Regulatory Submissions

BioPoint provides consultants with extensive experience in designing and developing successful global regulatory submissions.

Our background in regulatory document and submission preparation includes:

  • Abbreviated new drug applications (ANDA)
  • Biologics license applications (BLA)
  • Clinical trial authorization/application/exemptions (CTA/CTX)
  • Clinical trial notifications (CTN)
  • Common technical document (CTD/eCTD)
  • 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)