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Our lists highlight upcoming sites over the next 3 months and in planning with available spaces which may be of interest to you for your audit schedule.Â
We will assist with your product of interest, ultimately leading to you acquiring detailed product-specific reports and refine your 2025 audit plan.
Rephine will request and take into account your specific requirements for the audit and ensure that your product is included in the scope of the audit
The ability to review and request clarifications during the drafting of the audit report
Ensure your compliance early as a sponsor of the audit to ensure access to the report as early as possible
All information handled is strictly kept under confidential terms, including NDA or CDAs, from sponsors participating in the audit to the auditee information delivered to the audit sponsors.
Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.
EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.
Each sponsor receives a fully customised audit report tailored to their specific requirements, ensuring thorough coverage of their product interests in a product-specific chapter.
With our extensive network of local auditors spanning the globe, we have the capability to conduct and deliver audits in any country, ensuring comprehensive coverage and timely results.
We specialise in auditing a diverse range of global pharmaceutical drug suppliers, covering various product areas such as APIs, Excipients, GMP Intermediates, GVP, and more, all while maintaining strict adherence to both local and global compliance standards.
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