The Gold Standard in Life Sciences Product & Device Quality

Global experts in quality assurance & GxP compliance across pharmaceutical, biotech & medical device manufacturing supply chain

GMP Audit Services

We are deeply experienced GxP consultants,  auditors and practitioners. We’ve been proactively helping pharmaceutical and medical device companies around the world with these supply-chain quality assurance services for over 25 years.

GxP Consultancy

Our GxP readiness services assess and target improvements across all manufacturing systems and processes, ensuring there are no gaps in quality or compliance, in any phases of the product development and manufacturing lifecycle.

Global Audit Library

We assess and report on a whole range of manufacturing sites and product lines, producing off-the-shelf reports available for purchase. In fact, we offer the single largest repository of live reports (within three-year validity), spanning thousands of individual products.

Welcome to Rephine

Once a manufacturer has been ‘Rephined’, quality is assured.

We are product quality experts, serving the strictly regulated life sciences industry – encompassing pharmaceutical, biotech and medical device manufacturing supply chains globally. Our services extend right across the product development lifecycle – from raw materials/device components to patient delivery.

Highlighted offerings include:-

  • GxP readiness services
  • Digital transformation of manufacturing controls, including robotic capabilities
  • Quality Management System advisory service
  • Tailored services for the Medical Device market
  • Auditing services & reports including on-demand audits and re-validated off-the-shelf audit reports

With our honed processes, bespoke service design, appropriate use of technology, and audit report consistency, we have established an enviable reputation and are widely acknowledged to be the Gold Standard in our field.

Global Audit Library

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Search our Audit Library

Simply skip straight to a search to locate the reports covering the sites and products you require
 

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Browse the Audit Library

Browse our global GMP audit library to see the range and scope of live reports we have in stock

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Join an Audit in Progress

Specify your unique requirements for inclusion in an upcoming inspection and report, optimise the efficiency and cost control of your supplier auditing

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Commission a Bespoke Audit

For tailored needs, we conduct rigorous on-demand custom audits of pharma manufacturers globally

3PARL QUALANDRE HEADER Article

3PARL® Consortium grows stronger with Qualandre’s emphasis on ethical conduct and trustworthiness

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.
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Innovative Solutions for Cancer Diagnosis and Prevention

As we navigate the complexities of cancer care, there’s a shared commitment to driving change and ensuring equitable access to life-saving treatments. This year’s World ...
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3PARL OWLPHARMA BLOG HEADER 1@300x Article

Owlpharma joins 3PARL® to propel mission for ethical GMP supply chains in Life Sciences

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.
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Scientist chemist researcher doctor analyzing dna sample using medical microscope GxP Consultancy

Decoding the technological minefield – A tactical approach to maximising Life Sciences R&D Software implementations

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
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All change for computer software assurance in Life Sciences

Newly published FDA guidance on Computer Software Assurance (CSA), together with the second edition of the GAMP 5 guide, have shifted the emphasis away from ...
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3PARL PHARMA AUDIT BLOG HEADER LR Article

Pharma Audit among newest members of the recently launched initiative 3PARL®

3PARL® consortium welcomes Pharma Audit in its mission to assure consistent high standard of GMP supply chain audits in the life sciences industry   Stevenage, ...
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Clinical Trials Blog LR Blog

Navigating ICH E6 (R3) changes for GCP excellence with a digitalised QMS process

In the realm of clinical research, adhering to Good Clinical Practice (GCP) through the ICH E6 guidelines has become an essential part for global compliance. ...
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Navigating the Evolving Landscape of Cybersecurity for Medical Devices

Cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cybersecurity incidents have rendered medical devices ...
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Newly established 3PARL® consortium to assure global life sciences industry of consistent high standard of GMP supply chain audits

Rephine and Eurofins are acting against substandard audit practices with guarantees of the highest quality of inspection services & library
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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.

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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

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GMP Audit Services

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

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GxP Consultancy

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

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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

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
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REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

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