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CMC SUPPORT

Avrio offers a full range of CMC support through our affiliate, Irvine Pharmaceutical Services, Inc. With a twenty-year history of solid, dependable service and innovative approach to project management, Irvine offers its clients the quality, flexibility, and customer care your projects demand.

FULL RANGE OF CGMP SUPPORT SERVICES

Analytical Chemistry

  • Compendial Testing According to USP/NF, EP, BP, or JP Standards
  • Testing According to ACS and AOAC Methods
  • Testing According to Client-provided Methods

Analytical Development

  • Method Development and Validation
  • Process Validation Support
  • Cleaning Validation and Verification
  • Comparator Studies and Reference Standard Qualification

Biopharmaceuticals

  • Method Development and Validation
  • Product Characterization and Quality Control Testing

Inhalation/Nasal

  • Inhalation/Nasal Product Testing According to USP <601>
  • Device Evaluation
  • Product Characterization and Quality Control Testing
  • Method Development and Validation

Microbiology

  • Quality Control Testing
  • Research and Development Testing
  • Method Development and Validation

Stability Storage and Testing

  • Stability Studies
  • Standard Storage Conditions in Accordance with ICH Guidelines and Customized Storage Conditions
  • Chamber and Sample Management

Structural Chemistry

  • Extractable/Leachable Studies
  • Reference Standard Characterization
  • Structural Elucidation of Unknowns
  • Investigational Studies
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