Services

Route scouting and feasibility studies

  • Selection of synthetic schemes
  • Establishing PoC
  • Structure confirmation ( case to case)
  • Analytical method development  (case to case)
  • RLD sample confirmation
  • Samples generation for buy lead generation and client locking
  • Identifying KSMs with justification
  • Conclusion and  patent assessment report

Optimization studies

  • Process optimization including PAR & NAR, DoE, QbD, holding and stability studies
  • Critical Process Parameter (CPPs) studies what ifs, process engineering studies
  • Re-processing, recovery and cleaning procedures
  • Packing & storage conditions study
  • Reference and working standards
  • Effluent and mass balance
  • Process finalization and Lab validations data
  • Analytical development and method validations (case to case)

Kilo and Pilot lab and material build up

  • Material generation with consecutive three batches
  • Scale up study (identifying suitable equipment and MOC)
  • Scale learning and data for next scale

CRO

  • PO based, FFS and FTEs
  • Medicinal chemistry
  • Custom synthesis and Product development
  • Reference standards/Impurities
  • Ligands & Chiral
  • Degradants
  • Prep Column (Terms & Conditions)
  • Impurity identification and characterization
  • Deuterated / Labeled compounds
  • Sugar moieties
  • Peptides & Metabolites
  • Tech Transfers & Commercialization