Bioanalytical phase Monitoring

Clinical and Bioanalytical activities are critical stages where quality is prime and standard procedure

Clinical and Bioanalytical activities are critical stages where quality is prime and standard procedure and regulatory guidelines need to be complying in order to get approved and merchandise their product in the global market.

We offer Bioanalytical phase monitoring services to assess laboratory practices as per GLP regulations, adherence to the predefined internal standard operating procedures and other regulatory standards. We are experts in Bioanalytical data review and it’s compliance to the industry standards.

Our professionals are well experienced Quality Assurance auditors with Bioanalytical and Quality Assurance work experience. Our due diligence is a unique process of Root cause analysis, Investigations, Audit trail record review and Deviations from domestic and international regulatory specifications to which sponsor is intended to submit the data.

We monitor Bioanalytical phase analysis with predefined checklist to cover all the events. Independent monitoring of Bioanalytical phase is done through In-processing and Retrospective audits scheduled with the Bioanalytical centre.

Bioanalytical review includes :

  • Review of Method development and Validation
  • Review of Bioanalytical project data and Report
  • Operating procedures and protocol compliance
  • Bioanalytical sample storage and records
  • Instrumentation and sample processing
  • Review of chromatogram integrations and audit trials
  • Investigations and justifications
  • Event record deviations and CAPA
  • Qualifications and calibrations
  • GDP and GLP compliance