The Gold Standard in Life Sciences Product 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

Search Audit Library

Search our Audit Library

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

Browse Audit Library

Browse the Audit Library

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

Join Audit

Join an Audit in Progress

Specify your own particular requirements for inclusion in an existing, upcoming inspection and report, to maximise the efficiency and cost control of your supplier auditing.

Bespoke Audit

Commission a Bespoke Audit

For more bespoke requirements, we perform rigorous, on-demand custom audits of pharma manufacturers across the supply chain internationally.

doctor performing medical research lab Blog

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 reports, from raw materials to
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Vaccine injection bottles with white label in a row Blog

EU GMP Annex 1: How well has pharma adapted?

A few weeks ago, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for
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CE Mark MDSW Case Study Header Case Study

2023 Medical Devices CE Mark for a MDSW (Medical Device Software)

About this Case Study The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as
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Rephine Exhibit at India TrackWise User Group Mumbai – Sept 1st

Rephine to Exhibit at the Upcoming India TrackWise User Group in Mumbai on September 1st We’re thrilled to announce that the Rephine India team will
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Rephine Golden Ticket (Feed Ad) Event

Rephine Golden Ticket

With Rephine, everyone’s a winner! Thank you for taking the time to visit us! As you are a Golden Ticket winner, please take the opportunity
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Rephine agrees Chinese distribution partnership with Trackwise

Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions.   Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in
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Mock Inspection USA Case Study Header Case Study

2023 Mock Inspection USA Market

About this Case Study The case study involved a pharmaceutical company seeking to bring a product, manufactured in Europe, into the US market for commercialisation.
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Medical Devices service image.png Case Study

2023 Medical Devices Mock Inspection

About this Case Study The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA.
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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.

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library



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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  • Barcelona, Spain                               
  • +34 934 178065


  • Shanghai, China 


  • Hyderabad, India