Auditing
Facility and system audits
Independent GMP audits of facilities, utilities and quality systems, reported with clear findings and practical recommendations.
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Due diligence
Independent assessment of regulatory compliance, quality systems and risk for acquisitions, partnerships and contract manufacturing decisions.
Before a transaction, the compliance status of a facility is a material question. We assess the site, its quality system, its regulatory history and its open commitments, and report the risks and likely remediation effort in terms a deal team can use.
Scope
- Site and quality-system assessment
- Review of regulatory inspection history and open commitments
- Review of validation status and data-integrity controls
- Estimate of remediation effort and timeline
How we approach it
Independent
Findings are reported without a stake in the outcome of the transaction.
Decision-ready
Risks are expressed as remediation effort and timeline, not only observations.
Confidential
Work is conducted under appropriate confidentiality terms.
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Auditing
Supplier auditing and qualification
Audits and qualification programmes for API, excipient, packaging and service suppliers across your supply chain.
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