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Our comprehensive suite of consulting and advisory services includes quality management systems, mock inspections, equipment qualification/computerised system validation, and plant engineering assessments.
Our services extend right across the product development lifecycle – from raw materials/device components to patient delivery.
We offer a complete suite of services, which we can customise to suit the specific needs of our clients
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 can also deploy the TrackWise Digital Quality Management Software – a digital ecosystem to drive proactive quality across the supply chain, in addition to other QMS software technologies such as Veeva, Ennov and others.
Our QMS experts can also advise on the opportunities for digital transformation across GxP processes to ensure maximum impact.
We assess and target improvements as needed across all contributory manufacturing systems, processes, materials/products and manufacturing plants, to ensure there are no gaps in quality or compliance, across all phases of the site and product development, and manufacturing lifecycle.
For the fast-expanding field of medical devices – encompassing smart/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.
Case Study About this Case Study The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as …
Article Rephine to Exhibit at the Upcoming India TrackWise User Group in Mumbai on September 1st We’re thrilled to announce that the Rephine India team will …
Event With Rephine everyone’s a winner! Thank you for visiting us! Submit the form and take advantage of some sweet offers: 15% off library report*Or10% off …
Article Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions. Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in …
Case Study About this Case Study The case study involved a pharmaceutical company seeking to bring a product, manufactured in Europe, into the US market for commercialisation. …
Case Study About this Case Study The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA. …
Article Rephine now offering QMS services to medical device companies through new partnership. Stevenage, Hertfordshire, 28 July, 2023 – Rephine, the experts in quality assurance & …
Case Study About this Case Study The case study involved updating the Technical File documentation for more than100 IVD products according to Regulation (EU) 2017/746. The company …
General About these recordings Missed out on the insightful sessions and captivating discussions from our esteemed speakers at the Rephine Symposium? Don’t worry, we’ve got you …
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