Regulatory Services

  • Regulatory CMC writing new products & marketed products: CTD, NeeS, eCTD formats (Eg; IND, IMPD, NDA, ANDA, ANDS, MAA, DMF/EDMF,BLA)
  • Conversion of CMC dossiers in old NTA format to CTD
  • Life cycle maintenance; variations, SUPAC support
  • Expert report writing; QbR, QOS etc
  • Due diligence of dossier
  • Regulatory CMC strategy
  • Review of technical documentation
  • Assistance with API drug substance
  • Response to CMC queries
  • Regulatory submission and liaising with agencies