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.
Participating in audit scopes with an auditing partner grants access to expertise across the entire audit process. From audits conducted and managed by experienced professionals to end-to-end services, you benefit from their knowledge and procedures, ensuring thorough assessments and precise, customised reports for your compliance needs.
Within the audit scope, compliance complexities are managed with integrity and foresight. By partnering with providers like Rephine, you gain access to a full team, from operations to CAPA teams, ensuring close relationships with authorities and staying updated on regulatory changes. This comprehensive approach adeptly navigates challenges, upholding high standards and reducing risk, while meticulously managing and aligning your product and audit requirements with regulatory expectations.
Inclusion in audit reports ensures comprehensive product coverage, reducing compliance risks. Early audit sign-up demonstrates a commitment to compliance and mitigating complications.
For organisations using internal resources for auditing, they may not have the same insights and turnaround time as , leveraging insights into the site and scope, third-party auditors expedite the audit process, ensuring prompt delivery of reports while maintaining accuracy and thoroughness, ultimately streamlining operations and allowing your organization to
Early inclusion enables tailored requirements and vital input into the report, identifying overlooked areas and potential risks, fostering collaboration and a customised audit experience.
Audit involvement provides strategic decision-making opportunities, reducing administrative burdens. Early involvement streamlines the audit process, freeing internal resources and improving outcomes and business value.
Inclusion in audit reports ensures comprehensive product coverage, reducing compliance risks. Early audit sign-up demonstrates a commitment to compliance and mitigating complications.
Signing up for an upcoming audit ensures specific requirements are included. Observations are available within days, allowing greater customisation, creating timely, detailed reports, enabling informed decision-making.
Our lists highlight upcoming sites and audit types 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.
Unlock access to our April – June 2024 Optimised Audit List today by simply entering your information.
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.
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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