Third Party Audits

We help reduce audit burdens strategically

We are aware of the needs and expectations of pharmaceutical companies and of the auditing pressure their suppliers undergo. This led us to create a model that provides advantages to all parts delivering a high-end audit service.

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.

Our Audit Model

We look for the best audit organisation, avoiding time and efforts dealing with all the stakeholders to schedule the audits according to the sponsors’ deadlines and according the auditees’ schedule.

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.

Rephine Audit Process

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.

Audit Request

Start with pool of customers, then look for other sponsors interested, share the cost, and set up contract and agreements with audit sponsors

Shared Audits

We look for the most convenient solution to offer you the best price with shared costs and personalised reports

What you can expect from
our Gold Standard audit services

Timely and Tailored Reporting

Receive customised audit reports, including a dedicated chapter for your product of interest, with a guaranteed delivery within 8 weeks for a timely assessment.

Flexible Audit
Requests

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.

Draft Review
and Input

You will gain access the draft report before finalisation, enabling you to provide input, request additional information, and maintain transparency.

Exclusive Site
Audits

Obtain audit reports for sites that are challenging for most clients to access, ensuring comprehensive evaluations.

Expert Advisory
Services

Benefit from Rephine’s extensive knowledge base, particularly for sites that have undergone multiple audits.

Auditor Qualification
Assurance

Review and approve auditors’ CVs for confidence in their professional qualifications and auditing expertise, ensuring a knowledgeable and experienced audit team.

Why choose Rephine?

Confidentiality

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.

Impartiality

Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.

No Conflict of Interest

EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.

Personalised Reports

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.

Global Coverage

With local auditors all around the globe, we can perform and deliver audits to any country.

Audit Scope

We have expertise to audit a breadth of global pharmaceutical drug suppliers, and audit to all the relevant local and global compliance standards.

Rephine sets a very high bar for GMP auditing. Their oversight and impeccable reporting gives us the evidence we need to satisfy regulators and ensure patient safety at all times

Rephine is not only the most reliable company we have worked with, it has the most up to date library too!

The Covid-19 pandemic shone a light on supply chain fragility, especially in pharma. But throughout, Rephine was there to verify quality and keep record up to date. They were the calm and the constant in the storm

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Global Audit Library

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

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Let's get in touch

Email: [email protected]

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REPHINE HQ

Stevenage, UK
+44 1763 853135

REPHINE BARCELONA S.L.U

Barcelona, Spain
+34 934 178065

REPHINE CHINA

Shanghai, China

REPHINE INDIA

Hyderabad, India

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Third Party Audits

We help reduce audit burdens strategically

We are aware of the needs and expectations of pharmaceutical companies and of the auditing pressure their suppliers undergo. This led us to create a model that provides advantages to all parts delivering a high-end audit service.

Our Audit Model

We look for the best audit organisation, avoiding time and efforts dealing with all the stakeholders to schedule the audits according to the sponsors’ deadlines and according the auditees’ schedule.