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

REPHINE AUDIT GREEN GAP ANALYSIS ICON

Search our Audit Library

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

Browse the Audit Library

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

REPHINE AUDIT GREEN STAFF CUSTOMERS ICON

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

REPHINE AUDIT GREEN CUSTOM AUDITS ICON

Commission a Bespoke Audit

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

Medical Software as MD MedTech Guide Header Image (1500 x 844 px) Guide

When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.
Read More
Dmf case study header Case Study

Navigating DMF Registration in China with Rephine

Explore case study showing the development of a project for a new pharmaceutical manufacturing plant with the objective to fulfill GMP requirements and minimise risks ...
Read More
DMF blog image mar 25 Blog

Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF

Learn how to navigate DMF submission in China with Rephine’s expert guidance. From compliance reviews to NMPA approval — streamline your entry into the Chinese ...
Read More

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.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

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

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

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

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

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: enquiries@rephine.com
Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us