International Regulatory GMP Compliance Audits

'Audit readiness' Audits by PharmOut Compliance Consultants

PharmOut's pharmaceutical cGMP compliance consulting service includes:

• Compliance audits to determine current levels of compliance or audit-readiness to United States FDA, European EMEA and TGA (Australia) standards
• Preparation of an independent GAP analysis of GMP issues before the auditors arrive, improving your compliance and confidence.
• Support in getting ready for pre-approval inspections and site audits

Regulatory Inspections / Audits

PharmOut offers:

• Support and coaching for the proper handling of regulatory auditors and site approval inspections
• Support in preparing responses and action plans
• Preparation and implementation of plans to enhance GMP compliance

Post-Audit Remediation Programs

PharmOut services include:

• Support and coaching in the management of regulatory audit remediation programs
• Complete turnkey project management of GMP remediation programs
• Complete turnkey project management of Validation Programs
• Supplying experienced professional resources to support these activities

Compliance Auditing and Remediation to

• Australian, Therapeutic Goods Administration (TGA), regulating medicines, medical devices, blood, tissues and chemicals in Australia
• United States, Food and Drug Administration (FDA), regulating US Food and Drugs.
• Europe, European Agency for the Evaluation of Medicinal Products (EMEA)

PharmOut specialises in cGMP & Validation compliance in Australia and Asia.