engineering a better drug development process
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Analytical Services

The range of analytical services that we provide include:

  • New analytical methods development and transfer to the customer's site
  • Pharmacopeial methods verification
  • Analytical method validations using diversified instrumentation and traditional wet chemistry techniques based on ICH requirements
  • Pharmaceutical services with reference to pharmacopeias for raw materials, intermediates and dosage forms for release testing and one-off investigations
  • Stability studies at various temperature stations according to ICH requirements
  • Isolation and characterization of impurities, report generation and qualification, and inclusion into specifications
  • Dosage forms: dissolution, tablet hardness, thickness, disintegration and friability, and uniformity of mass
  • Testing of drug substances and drug products for light sensitivity, including and excluding packaging
  • Reference material and standards: controlling and supplying reference materials including securing reference  standard, testing and certification and then shipping to facilities requiring reference materials
  • Design, implement and validate cleaning procedures for processes that are compliant with current regulations
  • Primary container/packaging compatibility studies for various dosage forms, packaging development for drug substance and
    drug product
  • Identification of extractables from primary packing material
Analytical Services
drug product development | analytical services | medicinal chemistry | drug substanceDrug Substance Manufacturing
drug product development | analytical services | medicinal chemistry | drug substanceMedicinal Chemistry Services
Process Technologies for Drug Substancedrug product development | analytical services | medicinal chemistry | drug substance