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Data and Document Auditing
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| Polaris has experienced staff who can review your data and regulatory documents for consistency and compliance with regulations. Clear and consistent documents contribute to a faster approval time. |
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| Data and Report Audits |
- Stability protocols and reports
- Annual Product Reports
- Clinical Study Reports
- Investigator Brochures
- SAE narratives
- Analytical data vs. source documentation
- Contributions by various departments
- Chemistry Manufacturing Control (CMC) sections for NDAs and ANDAs and CGMP supporting documents
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| Data, Reports and Regulatory Submissions |
- Evaluate internal consistency
- Evaluate compliance with regulations and guidelines
- Compare NDA, BLA, clinical overview, or integrated summaries to individual study reports and records
- Compare study reports to the protocol, CRFs, data listings and database
- Review clinical, nonclinical and manufacturing sections of NDAs, ANDAs, and supporting documentation
- Assess technical transfer for manufacturing and test methods
- Review submitted method validations
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| To ensure internal consistency in reports, Polaris checks: |
- grammar, punctuation, spelling
- content with Table of Contents
- text to tables; tables to appendices; appendices to listings; listings to CRFs
- references (if requested)
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200 Commonwealth Court, Suite 101 
