QUANTIC REGULATORY SERVICES

• For clients with regulatory concerns, QRS focuses on supporting the company in rebuilding or protecting its reputation with regulatory agencies.

• Includes support and certification for 483s, recalls, Warning-Letters and Consent Decrees

• Consulting on regulatory requirements and interpretation

• Prepared response strategies and reports
• Attest to agencies on client progress
• Acted as an independent third party

• Audits of operations
• Review and certify
• Clinical/Bioequivalence Studies
• Product License
• Validation
• Facilities
• Laboratories
• Investigations
• Batch Records
• Management Controls
• Products
• 483 response and corrections
• Completed remediation plans
• Facilities and laboratories
• Corporate and site policies, standards, guidelines and SOPs

• Due Diligence Assessments