The Gold Standard in Life Sciences Product 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

Search Audit Library

Search our Audit Library

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

Browse Audit Library

Browse the Audit Library

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

Join Audit

Join an Audit in Progress

Specify your own particular requirements for inclusion in an existing, upcoming inspection and report, to maximise the efficiency and cost control of your supplier auditing.

Bespoke Audit

Commission a Bespoke Audit

For more bespoke requirements, we perform rigorous, on-demand custom audits of pharma manufacturers across the supply chain internationally.

Article

ValGenesis & Rephine Partner to Deliver Digital End-to-End Compliance Solutions for Life Sciences Companies

The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …

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Blog

EC Proposal Amending MDR & IVDR Transitional Provisions (2023)

EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …

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SQA PR Article 1 Article

Rephine to sponsor forthcoming Global Quality Assurance Conference

Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity.   …

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shutterstock 793279159 Blog

New EU GMP Annex 1 requirements: EMA says no deadline extension

An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …

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Article

Preparing to meet EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products

Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …

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Article

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by  Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …

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Blog

The roaring 20s: what a time to be Life Sciences’ Quality backbone

Bringing rigour to global supply chains as the reinvention of medicine continues by: Dr. Eduard Cayon, VP Audit Services, Rephine New waves of innovation in …

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Ebook

Practical Steps to Compliance with EU GMP Annex 1

About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …

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Event

CPHI 2022 Golden Ticket

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Where do you Need our Help?

For GMP Auditing, Quality Assurance & Regulatory Compliance, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library

Regulatory

Regulatory

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.
Social: Linkedin

Telephone:

Rephine HQ, UK
+44 1763 853135

Barcelona, Spain                               +34 934 178065











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