Services

We provide onsite and/or remote services including but not limited to:

• Consulting
  • Quality Management System (QMS)
    • Implementation
    • Remediation
    • Maintenance
  • Regulatory Enforcement Actions (e.g. FDA Form 483, Warning Letter)
  • Notified Body (NB), Certification Body (CB)/Registrar Findings
• Auditing
  • Gap Analysis
  • Internal Auditing
  • Supplier Auditing
  • Regulatory and/or ISO Mock Auditing
• Training
  • Complete QMS Training
  • Individual QMS Element Training
  • Top Management Training
  • Quality Manager Training
  • Root Cause Training
• Projects
  • Data Analysis
  • Complaint Handling
  • Corrective and preventive action (CAPA)
  • Other

Certifications