Regulatory Services

KriSan Biotech offers regulatory supports for consultation and CMC documentation preparation from early stage development to commercialization, including Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA).

Regulatory strategy and technical support
  • Evaluation of registration requirements from clinical (Phase 1~ 3) to commercial.
  • Regulatory support for small molecule, peptide, oligonucleotide, Antibody-drug conjugate (ADC) and High Potency API
  • Authority consultancy
Global submission
  • CMC sections for IND or IMPD
  • Prepare DMF, ASMF, JMF, CEP dossier
  • Registration documents in eCTD format
  • Registration service for Taiwan, US, EU, Japan..
Dossier management
  • Annual reports
  • DMF amendments
  • Post-approval change/ variation
  • Response to deficiency letters