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

Supplier Qualification in GxP Compliance: Strengthening Pharmaceutical Supply Chains

Supplier qualification is critical to GxP compliance and regulatory readiness. Discover how Rephine helps pharma companies manage supplier risks, ensure data integrity, and maintain supply ...
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GMP Raising the bar Blog series Header image May 25 Blog

How Data Integrity Audits Prevent Compliance Failures

Data integrity failures are a top reason for GMP violations worldwide. Learn how Rephine’s expert audits and consulting services safeguard pharmaceutical compliance.
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GMP Raising the bar Blog series Header image May 25 Blog

Best Practices in Cleaning Validation for GMP Compliance

Cleaning validation is essential to GMP compliance and patient safety in pharmaceutical manufacturing. Learn how Rephine’s science-based strategies ensure robust, regulator-ready cleaning validation programs through ...
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Revamping API Plant Header image case study June 25 Case Study

GMP Compliance for API Manufacturing: Requalifying a Fire-Damaged Plant

Learn how Rephine supported a full validation-led requalification programme to restore GMP compliance in API manufacturing after a major plant fire. Download the case study ...
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GMP Raising the bar Blog series Header image May 25 Blog

Understanding FDA Quality Metrics: Preparing for Compliance and Competitive Advantage

With FDA's growing focus on quality metrics reporting, pharmaceutical companies must go beyond traditional compliance. Learn how proactive data practices and QMM evaluations are shaping ...
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GMP Raising the bar Blog series Header image May 25 Blog

Risk Management in GMP: Best Practices for Compliance

Regulators now demand more than reactive GMP compliance—they expect risk-based control. Learn how Rephine helps you implement ICH Q9 principles and structured PQS governance to ...
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QMS IMP Header image case study May 25 Case Study

Building a QMS for IMP Operations to Ensure GMP Compliance

Learn how Rephine supported a biotech company in building a robust QMS to ensure GxP and GMP compliance for IMP operations. Download the full case ...
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QMS IMP Header image Blog case study May 25 Blog

How to Build a QMS for IMP Operations and Achieve GMP Compliance

Learn how to achieve GMP compliance and GxP readiness through effective QMS development for IMP trials.
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GMP Raising the bar Blog series Header image May 25 Blog

How Rephine Supports GxP Inspection Readiness

Rephine empowers life science companies to succeed in GxP inspections with a proactive approach to compliance. From mock audits to Annex 1 strategies and supplier ...
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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