Nowadays, many companies must face new challenges and situations that arise from new business opportunities: the development of a new product, the opening of new markets in new countries or geographical areas, agreements with international companies for a project on a global scale… This results in the need to comply with new or different regulations, not previously considered.
Opening to other markets, either in Europe, USA, Asia-Pacific, the Middle East or Latin America, requires the need of compliance to high standards of cGMP and the success in the subsequent inspections, a pre-requisite for the approval of new activities or products.
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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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After a rigorous process for becoming certified by Sparta, we have a powerful and experienced team to implement TrackWise systems according of each client’s requirements. These requirements are captured through different workshops and subsequent prototypes are made.
After a rigorous process for becoming certified by Sparta, we have a powerful and experienced team to implement TrackWise systems according of each client’s requirements. These requirements are captured through different workshops and subsequent prototypes are made.
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