Compliance

CyberVal provides a wide range of compliance services designed to achieve compliance by developing an appropriate interpretation of regulation based on client-specific scientific and business principles.

Targeting compliance goals eliminates misguided resource allocation. Knowledge of applicable guidance and industry practices provides reasonable assurance that various compliance objectives are realized.

CyberVal specializes in biotech startup companies and organizations in transition from non-regulated to regulated environments.

• Current Good Manufacturing Practices
• 21 CFR Part 11
• Health Insurance Portability & Accountability Act
• Sarbanes-Oxley
• Master Plans Development
• Consent Decree Remediation
• FDA Form 483 Responses
• Quality Audits
• Assessments