The Gold Standard in Life Sciences Product & Device Quality
Global experts in quality assurance & GxP compliance across pharmaceutical, biotech & medical device manufacturing supply chain
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.
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.
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
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
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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.
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
Email:Â enquiries@rephine.com
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REPHINE HQ
- Stevenage, UK
- +44 1763 853135
REPHINE BARCELONA S.L.U
- Barcelona, Spain               Â
- +34 934 178065
REPHINE CHINA
- Shanghai, ChinaÂ
REPHINE INDIA
- Hyderabad, India                Â
For careers enquiries: please email our team at careers@rephine.com. We’re unable to consider applications received through this form.
