Menu
Our comprehensive suite of consulting and advisory services includes quality management systems, mock inspections, equipment qualification/computerised system validation, and plant engineering assessments.
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.
Blog From repeatable rigour and experienced expertise, to highly ethical and transparent practices Alasdair Leckie, VP Audit Services, Rephine As in any other area of life …
Pharmaoffer, the ‘Amazon’ of API suppliers, will link its customers to Rephine’s vast library of live, off-the-shelf GMP audit reports of manufacturers around the world …
Article Live online event to be held on April 17th-18th 2023 and will feature deep domain expertise within the scope of Quality Assurance. Stevenage, Hertfordshire, 27th …
Article 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, …
Blog EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …
Article Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity. …
Blog 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 …
Article 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. …
Article 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 …
REPHINE CHINA
REPHINE INDIA
Sign up to our newsletter to get the latest news about Rephine and industry news.
