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Analytical Development & Validation

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Agno Pharma offers a wide range of analytical development and validation services to support your drug discovery, research and development, and commercialization programs. Our analytical method development and validation services are seamlessly integrated into a complete development program driven by an experienced dedicated team. Our innovative problem solving approach uses a combination of analytical techniques and instrumental methods to resolve any issues you may come across in your analytical project. We have state-of-the-art analytical instruments such as HPLC-MS, HPLC, Headspace-GC, GC, etc.Our compliance with both GLP and cGMP ensures all validation needs can be met throughout the drug development lifecycle. Validation is done to FDA and/or ICH guidelines. We have successfully developed and validated the following analytical methods.
  • Assay
  • Related Substances
  • Residual Solvents
  • Potential Genotoxic Impurities
  • Impurity Identification & Characterization
  • Extractables and Leachables
  • Forced degradation studies
  • Reference standard qualification
  • Chiral drugs
  • Cleaning verification

Custom Synthesis & Manufacturing
Chemical Process Development
API Section of IND
High Potency APIs
Medicinal Chemistry FTE
Analytical Development & Validation
ICH Stability Storage & Testing
Sourcing, Logistics & Testing