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Late-Phase Analytical Development


Late-Phase Analytical Development

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Method Development & Validation for NDA/ANDA Submission

  • Late-phase method development for API and drug products (impurity, dissolution etc. )
  • Full validation package for regulatory submission
  • Re-validations
  • Structure elucidation
  • Degradation pathway elucidation
  • Extractables & leachables analysis

GMP Release of Late-phase and Commercial API/Drug Product

  • Clinical material release, post-approval API/drug product QC surveillance
  • Surveillance test

Development & Manufacturing Support

  • In-process analytical support for DOE
  • Process characterization and validation

GMP Compliant Laboratories

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