Partnering with Rephine ensures regulatory expectations for product-specific chapters in audit reports are met, emphasising their importance for traceability and compliance accuracy. We provide detailed reporting with thorough product-specific chapters, high compliance rigor, and transparent processes throughout your audit. Your input ensures you receive customised, consistent reports, supporting your audit management effectively.
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.
We will assist with your product of interest, ultimately leading to you acquiring detailed product-specific reports and refine your 2024 audit plan.
If you have any questions about the upcoming list, complete the form and our dedicated team will be happy to help.
Wherever you are on your QA journey, we’ve got you covered.
Our end-to-end worldwide GMP Auditing services covers across multiple sites, so we streamline your planning, saving time and effort.
Experience our thorough audits and collaborative approach, reducing your planning burden and instilling confidence in our efficient management as a leader in quality assurance and GxP compliance.
We take pride in trusted partnership values to ensure reliability and professionalism throughout our services.
GxP Consulting and Regulatory Services positions us as your dedicated strategic partner for achieving business objectives.
Receive customised audit reports tailored to your requirements, ensuring comprehensive coverage of your products of interest, delivered within 8 weeks for timely assessments.
We handle every aspect of end-to-end audit management, and even cater to individual requirements, address previous observations, or request focus on specific areas to tailor the audit to your needs.
You will gain access to the draft report before finalisation with observations being addressed within days, enabling you to provide input, request additional information, maintaining transparency.
We have close relationships with audit sites which are challenging for most clients to access, so you will be able to obtain audit reports exclusively, ensuring comprehensive evaluations.
Benefit from Rephine's extensive knowledge base, above and beyond approach, and regulatory compliance assistance, 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 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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