Our model, crafted in response to the needs and expectations of pharmaceutical companies amidst supplier auditing pressures, delivers high-end audit services. Ensuring impartiality and independence from supplier-customer dynamics, we prioritise regulatory compliance and standards adherence, free from conflicts of interest.
Once the audit is contracted by the audit sponsors, we initiate our process, setting up the audit days – according the auditee schedule and sponsors’ deadlines. Once the audit is arranged, we look for the best qualified auditor team and Qualified auditors to best address the audit.
We take care of the entire audit lifecycle from audit preparation, execution, reporting and CAPA follow-up to allow you crossing out the audits to your suppliers from your list.
Receive customised audit reports, including a dedicated chapter for your product of interest, with a guaranteed delivery within 8 weeks for a timely assessment.
We handle every aspect of end-to-end audit management, and cater to specify requirements, address previous observations, or request focus on specific areas to tailor the audit to your needs.
You will gain access the draft report before finalisation, enabling you to provide input, request additional information, and maintain transparency.
Obtain audit reports for sites that are challenging for most clients to access, ensuring comprehensive evaluations.
Benefit from Rephine's extensive knowledge base, particularly for sites that have undergone multiple audits.
Review and approve auditors' CVs for confidence in their professional qualifications and auditing expertise, ensuring a knowledgeable and experienced audit team.
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 receive a complete report with the information related to the products of their interest and the inclusion of the revision of their specific requirements.
With local auditors all around the globe, we can perform and deliver audits to any country.
We have expertise to audit a breadth of global pharmaceutical drug suppliers, and audit to all the relevant local and global compliance standards.
3PARL® sets new presidential standards for manufacturing supply chains. As one of the consortium’s founders, Rephine are proud to be dedicated to upholding the highest quality and safety standards, guaranteeing that products are adhered to global GMP regulations and quality standards.Â
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
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