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

GMP Raising the bar Blog series Header image May 25 Blog

From Mock Inspection to Governance: Building a Roadmap

A mock inspection is more than a rehearsal — it’s a chance to transform gaps into governance. Explore how structured CAPA and QRM can build ...
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GMP Raising the bar Blog series Header image May 25 Blog

Operationalizing ALCOA+ in Digital GxP Systems

As pharma moves to digital platforms, ALCOA+ must be operationalized across QMS, LIMS, and ERP systems. Discover strategies to safeguard compliance and data integrity.
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Medical Device Guide

Manufacturing Process Validation for Medical Devices

This whitepaper explains how to plan and execute manufacturing process validation for medical devices under EU MDR & IVDR, aligned with ISO 13485 and ISO ...
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GMP Raising the bar Blog series Header image May 25 Blog

The Future is Hybrid: Annex 11, Annex 22 & GxP Compliance

The EMA’s 2025 draft updates highlight a hybrid future for pharma. Learn how unified governance of documentation, systems, and AI strengthens GxP compliance.
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GMP Raising the bar Blog series Header image May 25 Blog

Integrating AI into QMS: Annex 22 & GxP Compliance

As Annex 22 highlights AI in pharma, QMS integration takes centre stage. Explore governance, validation, and oversight strategies to achieve GxP compliance.
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微信图片 20250804170004 40 Blog

Deviation Management and Digital Tools in Pharma – Rephine Insights from CMC China

How can pharmaceutical companies turn everyday quality challenges into opportunities for improvement? At CMC China 2025, Rephine Consultant Ivan Zhang explored how a strong quality ...
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Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

Digital QMS Transformation for Biopharmaceutical CDMO

A leading biopharmaceutical CDMO partnered with Rephine to replace manual quality processes with a validated digital QMS, improving efficiency and compliance. Learn how the two-phase ...
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GMP Raising the bar Blog series Header image May 25 Blog

Validating AI Models in Pharma: Annex 22 & GxP Compliance

As AI integrates into pharma manufacturing, Annex 22 sets new expectations for validation. Learn how to ensure reliable models with strong data, oversight, and compliance.
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GMP Raising the bar Blog series Header image May 25 Blog

How to Prepare for Annex 22: EMA’s AI and Machine Learning Guidance for Pharma Manufacturing

The EMA’s draft Annex 22 marks the first regulatory framework for AI and machine learning in GxP manufacturing. Learn the key requirements, from model validation ...
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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                               

Contact Us