GxP Document Review Services
Montrium offers services for the independent QA review of pharmaceutical development records and Essential Documents in accordance with regulatory requirements and SOPs (Client or Montrium). We have experience reviewing the following documents:
- Project Management Plans
- Study protocols
- Investigator’s Brochures
- Subject Informed Consent Forms
- Clinical Monitoring Plans
- Data Management Plans
- Case Report Forms
- Statistical Analysis Plan
- Clinical Study Reports
- GLP Reports
- Safety Management Plans
- SAE narratives
- Manufacturing Batch Records
- IMP Labels
- Stability protocols and reports
- Analytical Method Validation protocol and reports
- Analytical data versus source documentation
- Computer Systems Validation records
Please contact us to learn more about the specific GxP consulting services you are interested in.
“Montrium offers services for the independent QA review of pharmaceutical development records and Essential Documents in accordance with regulatory requirements and SOPs.”
