GxP Consultancy

We help drug and device manufacturers bring the best possible product to market, in full and demonstrable compliance with the latest GxP standards

Consulting & Advisory services

We are product quality experts, serving the strictly regulated life sciences industry – encompassing pharmaceutical, biotech and medical device manufacturing supply chains globally. 

Our services span the entire product development lifecycle, from raw materials and device components to patient delivery, providing a seamless continuum of support.

We tailor our offerings to meet the distinct requirements of each client, by offering a comprehensive suite of consulting and advisory services, including quality management systems, mock inspections, equipment qualification, computerised system validation, and plant engineering assessments.

Why choose Rephine?

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Digital Mindset

We harness technological transformation to achieve good practices in manufacturing and beyond (GxP), and to progress risk management and industry sustainability

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High Industry Standard

We maintain a continuous and fluent relationship with local and international organisations related to GxP compliance and validation

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Innovative and Flexible

We specialise in complex and strategical projects that require critical thinking and ground-breaking tailor-made solutions

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Long Term Relationships

We are a strategic partner and as such our clients rely on our expertise and commitment to deliver the best results overtime

Discover our suite of GxP Consultancy Services

GxP Readiness

Identify and enhance manufacturing systems, processes, and products to ensure compliance and quality throughout product development and manufacturing.

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Engineer servicing server rows

Computer Systems Validation

We ensure our customers deploy high quality, compliant technology systems while maintaining and assuring data integrity.

Whether on-premise or cloud, waterfall or agile or something in between, our experts have validated systems across the value chain including labs, pre-clinical, clinical, regulatory, quality, manufacturing, supply chain and ERP.

QMS Advisory

Our Quality Management System (QMS) Advisory service helps our customers to achieve a systematic approach to Quality design and maintenance, and optimised business processes.

We are also partners of premier QMS software technologies and digital ecosystem solutions to drive proactive quality across client’s supply chain. Our QMS experts can also advise on the opportunities for digital transformation across GxP processes to ensure maximum impact.

Doctor working on computer
close up chief researcher scientist adjusts microscope time coronavirus experiment

Medical Devices

For the fast-expanding field of medical devices, encompassing smart and digital devices as well as health tracking apps and software as a medical device.

Our tailored service follows the latest global regulatory frameworks and manufacturing requirements specific to this sector.

GxP Consultancy

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

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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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