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Method Validation

Home Method Validation

Our team of experts is having the rich experience in developing, optimizing and validation the methods as per international guide lines such as:

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  • ICH CGP & GLP
  • US FDA
  • EuraChem
  • European
  • AOAC
  • Customer provided

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Our expertise in Method Development and Validation ranges in

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  • Assay/Potency, Purity/Impurity, Dissolution
  • Cleaning Validation Analysis (Specific and Nonspecific analyses)
  • Assay, Impurity and Dissolution methods for Comparator products
  • Residual/Impurities Testing
  • Leachables and Extractables
  • Excipients
  • Antimicrobial Efficacy Test
  • Microbial Limit Test
  • Bacteriostatis/Fungistatis for Sterility
  • Inhibition/Enhancement Screening for Endotoxin
  • ELISA
  • Thermal Cycler and qPCR

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Protocol Writing for

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  • Method Validation / Qualification / Verification
  • Method Transfer
  • Stability Studies

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