Analytical Development




CAPABLE SUPPORT OF MULTIPLE DOSAGE FORMS

  • Injectables (lyo and non-lyo)
  • Solids, semi-solids, and liquids               
  • Inhalation/Nasal
  • Transdermal

Irvine’s analytical development group has experience in support of various dosage forms within the generic and branded pharmaceutical industries. The team’s diverse background has enabled Irvine to develop an in-depth understanding of all facets of the drug development process. In addition, Irvine offers extensive experience in gap analysis and remedial validation of existing methodologies to comply with current CDER/ICH guidelines for validation.

As development partners, we design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.

EXTENSIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION SERVICES

  • Assay and related substances
  • Chromatographic purity
  • Stability indicating assays
  • Forced degradation studies
  • Dissolution
  • Gap analysis and remedial validation
  • Residual solvents
  • Extractables/Leachables
  • Chiral drugs
  • Cleaning procedures
  • Characterization of reference standard
    and drug substances
  • Process validation support
  • Method transfer/training
  • Formulation development and product
    deformulation support
  • Comparative studies
  • Reference standard qualification
  • Counterfeit product evaluation
  • Vendor qualification



REQUEST A PROPOSAL

INSTRUMENTATION

DOWNLOAD FACT SHEET