Our comprehensive support for full compliance of medical devices, offering you the peace of mind you deserve. + More
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.
We harness technological transformation to achieve good practices in manufacturing and beyond (GxP), and to progress risk management and industry sustainability
We maintain a continuous and fluent relationship with local and international organisations related to GxP compliance and validation
We specialise in complex and strategical projects that require critical thinking and ground-breaking tailor-made solutions
We are a strategic partner and as such our clients rely on our expertise and commitment to deliver the best results overtime
Identify and enhance manufacturing systems, processes, and products to ensure compliance and quality throughout product development and manufacturing.
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.
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.
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.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
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
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
REPHINE HQ
REPHINE BARCELONA S.L.U
REPHINE CHINA
REPHINE INDIA
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