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, or European EMEA standards and TGA (Australia)
- Preparing an independent GAP analysis of GMP issues before the auditors arrive, improving your compliance and confidence.
- Support with 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 & implementation of plans to enhance GMP compliance
Post Audit remediation programs
PharmOut services include:
- Support and coaching for 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 the US Food and Drugs.
- Europe, European Agency for the Evaluation of Medicinal Products (EMEA)
PharmOut specialises in cGMP & Validation compliance services in Australia and Asia.
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Validation
GMP Compliance
Drug / Medical Device Registration
Lean Pharma