Analytical Services

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We provide state of the art analytical services to some of the leading pharmaceutical companies in the world.  Our extensive pharmaceutical experience provides for regulatory GMP/ICH/USP compliance along with scientific excellence.  We bring you results with interpretation and direction to ensure your project's successful completion.

• Finished Product Testing to global standards (USP, PhEur, JP)
• Excipient testing 
• API and Intermediate testing
• Analytical method transfer
• Particulate Matter by Light Obscuration
• Particulate Matter by Microcopy

• Methods development for potency and impurities
• Analytical method validations per ICH guidelines
• Analytical method assessments and improvements
• Analytical method transfer

• Stability Storage in accordance with ICH guidelines
• Stability program implementation
• Stability testing, trend analysis, and reporting
• Annual GMP stability product review
• All stability chambers are monitored 24 hours

• Extraction-Migration testing
• Extractable-Leachable testing
• USP Physiochemical testing for plastics
• In-use stability
• Container closure integrity

• Methods development for active ingredient and cleaning agents
• Swab recovery validation and analysis
• Protocol development and execution
• Report generation

We combine a long history of working with contract manufacturing organizations with current understanding of today's regulatory needs.  From quality agreements to satirical tools, from laboratory investigations to regulatory guidance, we have the expertise and experience to help you navigate through industry regulatory requirements:

• Process Validation: Process assessment; Validation design and protocol development; Protocol execution; Sample testing; Report writing

• Product Support: Impurity investigations; Manufacturing investigations; Annual GMP reviews

• Packaging System Characterization: Quality systems review and management; Management of product transfer; Quality systems implementation for contract manufacturing; Management and performance of validation reports; Pre-approval inspection preparation