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During the pandemic, we applied an agile approach to maintaining highest standards, harnessing the latest tools and techniques to conduct virtual audits as a temporary measure at times when physical inspections were not possible. We now harness those same techniques as an invaluable supplement to on-site inspections, allowing us to focus our face-to-face time where it is needed most.
We conduct rigorous audits of pharma manufacturers across the supply chain, to ensure strict GMP standards are being met – fulfilling applicable regulations and ensuring patient safety.
Rephine’s methodology ensures total impartiality and confidentiality during the whole audit process.
Our deeply-experienced Regulatory experts can provide help right across the regulatory lifecycle, to ensure that dossiers are up to scratch pre-, during, and post-submission.
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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