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product hightlights

Chemistry, Manufacturing and Controls

Our team supports your chemistry, manufacturing and controls (CMC) development by:

  • Identifying contract manufacturers specific to your needs.
  • Managing the contract manufacturing and/or analytical testing of the drug substance and/or drug product.
  • Providing regulatory guidance in setting appropriate manufacturing specifications, in method development and /validation and in conducting stability studies relevant to the clinical phase of development
  • Consulting on GMP training and GMP feasibility audits, as well as producing standard operating procedure documentation writing
  • Coordinating with contractors to ensure all development work is performed to your specifications and meets your timeline
  • Preparing quality/CMC summaries for regulatory submissions
Customer Value
Your Gateway to Asian Life Science