ORCA’s team of compliance experts specialize in both compliance and validation services as an integral part of our clients' total compliance strategy. Our dedicated team is uniquely qualified to optimize any validation or compliance effort by applying their industry and regulatory experience. ORCA ensures overall adherence to Federal Regulations and GCP Guidelines. Below is a brief list of compliance services which may be included in any proposal:
- Compliance Assessments
- Clinical/Technical Gap Analysis and Risk Assessment
- System Audits
- GCP Audits of Clinical Sites
- CRO/Vendor Audits
- GCP Compliance Consulting and Auditing
- Pre-FDA Inspections
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