Services

Quality Assurance

A majority of Alava clients request Quality support as part of the project scope, and the team has expanded to provide excellent depth and value at levels from manager through VP. We monitor current US and international regulations, guidance documents and enforcement trends. Alava specializes in addressing sponsor responsibilities for outsourced activities, and finding an appropriate approach for novel or challenging technologies. Alava can carry all QA-related responsibilities requested by a sponsor including product disposition.

  • QA document system startup and maintenance
  • Quality Agreements for CMO’s and testing labs
  • Batch Record and Testing Record review and approval
  • QA audits and Pre-Approval Inspection preparation
  • Facility and utility validation and compliance
  • Investigations and compliance remediation
  • Support for stage-appropriate method and process validation
  • Documented training
  • Review key technical and nonclinical reports