About Us

Rephine is a global team of GxP Audit and compliance specialists. Founded in 1998, we have spent nearly three decades auditing, assessing and advising for life sciences companies worldwide. There are around 125 of us, in over ten countries, working from offices in the UK, Spain, China and India.

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Most of our work starts with a question about somebody else

Can this supplier be relied on? Is this site as good as its paperwork suggests? What will a regulator make of it?

A large part of it starts from the other side of the table, with companies facing an audit or an inspection of their own. We work both positions, which is why our reports are recognised and accepted by regulators worldwide, and why the sites we assess keep letting us back in.

Shaped by what our clients need

Rephine started in GMP auditing. Everything since has been added because clients asked for it: reports they could draw on immediately, consultants to close the findings, validation and qualification, quality systems, training, and support for the times they were the ones being audited.

That is why the range looks the way it does. It is not a portfolio strategy. It is nearly thirty years of answering the next thing quality teams needed, which is also why you are unlikely to outgrow us.

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Rephine UK Team group photo

The judgement you are buying sits with our people

Whatever we take on, a named specialist owns it. Our team page introduces the leadership group and the technical experts who run our audits, validation projects, quality systems and training, and beyond.

We grow our own specialists

Our GxP specialists are the best of the best, so a good deal of what we do is developing them. We use the same training practice we run for clients, through Rephine Academy. If that sounds like the career you want, our careers page explains how it works here.

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We take pride in our Global Audit Library achievements

We offer the single largest repository of reports within three year validity, spanning more than 2,500 individual products, so whatever you’re looking for there’s a good chance we’ve already got it covered.

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Frequenty asked questions

What does Rephine do?

Rephine audits pharmaceutical, biotechnology, medical device and related manufacturing sites and suppliers on behalf of the companies that depend on them. We also support companies preparing for an audit or a regulatory inspection, and provide the GxP consultancy, validation, quality systems work and training that follows.

Pharmaceutical and biotechnology manufacturing, medical devices and diagnostics, veterinary medicines, cosmetics and food supplements. Our clients run from early-stage companies through to large multinationals.

1998. We have worked with life sciences companies across Europe, the Americas and Asia ever since.

Our head office is in Stevenage, United Kingdom, with further offices in Barcelona, Shanghai and Hyderabad. Colleagues work from several other countries too.

Yes. Auditee support is a department in its own right, covering the preparation beforehand, support while the audit is happening, and the follow-up once findings are issued.

Let's get in touch

Email: [email protected]

Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 
 

REPHINE INDIA

  • Hyderabad, India                               
 

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

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

REPHINE AUDIT BLUE INOVATION CONVOS ICON

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

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