Menu
We have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GMP compliance systems
The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives.
Improving both product and process understanding, in combination with quality risk management, will support the establishment of an appropriate control strategy for consistent product quality and improved process performance
The fundamental GMP requirement for demonstrating adequate process control and the ability to manufacture reproducible product with the established quality.
We offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems
Rephine’s wide experience working both with pharmaceutical laboratories and directly with the main actors involved in the supply chain, allows us to address different risk management strategies and to easily respond to issues.
Our experience in GCP and GVP has supported clients in the changing pharmaceutical industry. Many companies are constantly filing drug applications for new medicines and new markets for existing medicines
All the modalities are taught by professionals with extensive experience in each of the subjects covered, both from the technical and regulatory point of view.
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 …
REPHINE CHINA
REPHINE INDIA
Sign up to our newsletter to get the latest news about Rephine and industry news.
