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

UKCA Marking Header image Guide

Understanding the UKCA Certification for Medical Devices

Navigating UKCA certification is essential for manufacturers seeking access to the Great Britain market. Understanding the regulatory landscape, transitional provisions, and compliance steps is key ...
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Understanding Computer System Validation and Data Integrity Compliance

In today’s fast-evolving regulatory landscape, maintaining compliance with Computer System Validation (CSV) and Data Integrity standards is more critical than ever. Organisations across the pharmaceutical, ...
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Key Deadlines Header image Ebook

Key Deadlines for Medical Device Manufacturers under MDR and IVDR

Discover everything you need to know about MDR and IVDR compliance timelines for 2025. This eBook provides actionable insights to help manufacturers stay compliant and ...
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rems audits Guide

REMS Program Audits: Ensuring Safety and Compliance

Navigating the FDA’s Risk Evaluation and Mitigation Strategy (REMS) requirements can be challenging, but it is critical for ensuring medication safety and regulatory compliance.
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AI CSV Jan 2025 blog Blog

Considerations for the Use of Artificial Intelligence in Regulatory Decision-Making for Drugs and Biological Products

In January 2025, the FDA issued a draft guidance to industry and stakeholders on the use of artificial intelligence (AI) to generate information or data ...
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AIQSV guide header image CSV

Streamlining Analytical Instrument Qualification & System Validation (AIQSV) Guide

The Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) is an essential resource for pharmaceutical laboratories striving to meet ...
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GMP Design Review Guide header image CSV

GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

An early-stage design review ensures your facility meets GMP standards, minimises risks of cross-contamination, and optimises efficiency—setting your project up for success from the start.
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mock inspection blog header Blog

Mock Inspections: How to Prepare for FDA Compliance in the OTC Market

Ensuring Success in FDA Inspections for OTC Products: The Role of Mock Inspections
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Essential Guide to EU GSPR Compliance for Medical Devices

Our guide simplifies GSPR compliance, helping medical device companies meet EU safety standards, streamline CE marking, and get market-ready faster.
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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