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.

Copy of Gold standard auditing Blog header Blog

Defining the Gold Standard: what does this mean in auditing?

From repeatable rigour and experienced expertise, to highly ethical and transparent practices Alasdair Leckie, VP Audit Services, Rephine As in any other area of life …

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Rephine announces exclusive partnership with Pharmaoffer, as the only GMP audit services provider on the online marketplace

Pharmaoffer, the ‘Amazon’ of API suppliers, will link its customers to Rephine’s vast library of live, off-the-shelf GMP audit reports of manufacturers around the world …

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Rephine unveils agenda for Rephine Virtual Symposium 2023

Live online event to be held on April 17th-18th 2023 and will feature deep domain expertise within the scope of Quality Assurance. Stevenage, Hertfordshire, 27th …

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ValGenesis & Rephine Partner to Deliver Digital End-to-End Compliance Solutions for Life Sciences Companies

The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …

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EC Proposal Amending MDR & IVDR Transitional Provisions (2023)

EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …

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SQA PR Article 1 Article

Rephine to sponsor forthcoming Global Quality Assurance Conference

Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity.   …

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New EU GMP Annex 1 requirements: EMA says no deadline extension

An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …

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Preparing to meet EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products

Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …

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Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by  Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …

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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                               

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