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We are always aiming the same target: to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product.
Project management for development/implantation of quality systems for new plants, processes and products.
Advice on the definition or optimization of the structure of the quality unit and the distribution of responsibilities.
Writing or updating quality system documentation: Policy, Quality Manual, Standard Operating Procedures (SOPs), etc.
Support and technical assistance in quality areas (Batch Review, Deviation and Layer Management, etc.)
Evaluation of regulatory and quality requirements applicable to each industry/process.
Quality System Internal Audits and Definition of the associated Action Plans.
Systems and Processes Risk Analysis.
GxP Compliance and Inspection Preparation
We strive to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product, considering the applicable regulatory requirements and national and international guidelines.
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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