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.

The team at Rephine has consistently delivered exceptional support in GMP auditing for our suppliers. Their thorough approach and attention to detail have helped us maintain the highest standards of quality and compliance. We highly recommend their services for any organization seeking rigorous audit solutions.

We have contracted API manufacturing sites in many countries and Rephine makes our business efficiency and cost reduction! Rephine's audit reports are clear and well-organized to read. They have high qualified auditors which we believe trustworthy company!

Rephine sets a very high bar for GMP auditing. Their oversight and impeccable reporting gives us the evidence we need to satisfy regulators and ensure patient safety at all times

Rephine is not only the most reliable company we have worked with, it has the most up to date library too!

The Covid-19 pandemic shone a light on supply chain fragility, especially in pharma. But throughout, Rephine was there to verify quality and keep record up to date. They were the calm and the constant in the storm

Global Audit Library

Search our Audit Library

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

Browse the Audit Library

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

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

Commission a Bespoke Audit

For tailored needs, we conduct rigorous on-demand custom audits of pharma manufacturers globally

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 ...

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 ...

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 ...

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.

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 ...

Blog

Transitioning from FDA QSR to QMSR: What Medical Device Companies Need to Know

The FDA has finalized a major update to 21 CFR Part 820, transitioning from the long-standing Quality System Regulation (QSR) to the new Quality Management ...

Blog

Why Quality Management Maturity (QMM) Is the Future of Pharmaceutical Compliance

The FDA and EMA are raising the bar—basic GMP compliance is no longer enough. Learn how Quality Management Maturity (QMM) drives continuous improvement, reduces risk, ...

Case Study

Validating an S/4 HANA ERP Upgrade for Medical Device Compliance

Explore how Rephine helped PALEX validate their S/4 HANA ERP system to meet EU medical device regulations, ensuring traceability, risk control, and operational efficiency.

Blog

EMA Updates Guidance on Third-Party GMP Audits: Rephine Strengthens Conflict of Interest Controls

The EMA has updated its guidance on third-party GMP audits, reinforcing the need for independence and conflict of interest management in supplier qualification. Rephine responds ...

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.

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

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

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.

Email: [email protected]

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REPHINE HQ

Stevenage, UK
+44 1763 853135

REPHINE BARCELONA S.L.U

Barcelona, Spain
+34 934 178065

REPHINE CHINA

Shanghai, China

REPHINE INDIA

Hyderabad, India

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GMP Audit Services

GxP Consultancy

The Gold Standard in Life Sciences Product & Device Quality

GMP Audit Services

GxP Consultancy

Global Audit Library

Welcome to Rephine

Once a manufacturer has been ‘Rephined’, quality is assured.

Global Audit Library

Search our Audit Library

Browse the Audit Library

Join an Audit in Progress

Commission a Bespoke Audit

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.

Global Audit Library

GMP Audit Services

GxP Consultancy

Digitalisation

Let's get in touch