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.
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 …
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 …
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 …
Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions. Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in …
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. …
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. …
Rephine now offering QMS services to medical device companies through new partnership. Stevenage, Hertfordshire, 28 July, 2023 – Rephine, the experts in quality assurance & …
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 …
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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