Compliance

Inspection Readiness & Auditing Support

• Inspection Preparation & Assessment

• Coaching

• Due Diligence

• Third-Party Audit

Health Authority Response & Remediation

• Authority Response

• Remediation Support

• On-Site Remediation

Other Compliance Support

• Reviews of QA/QC systems

• GMP Reviews (auditing construction and installation)

• Process Validation

• Computer System Validation

• Training (Compliance and Regulatory Affairs)

• Annex 1 Assessment

• Contamination Control Strategy

• Internal Audits

• Supplier Audits & Assessments