Rephine has been awarded the prestigious “Industry Partner of the Year” award for companies that work with or alongside generics and biosimilars manufacturers and suppliers. As the leading pharmaceutical consultancy, Rephine provides both GMP and GCP auditing services as well as a wide range of clinical and regulatory services to pharmaceutical, medical device and biotechnology industries worldwide.
Rephine’s unparalleled support to the pharmaceutical industry has led to the award at The 2016 Global Generics and Biosimilars CPhI. Nominees for this category were from industry partners such as; logistics providers, contract research organisations, contract-manufacturers, law firms and regulatory consultants.
Dr. Rino Coladangelo, CEO at Rephine says: “Rephine is extremely honoured by this award. It brings the Rephine team and me a great amount of joy to see the organisation recognised by its peers for its continual support to the industry”
Rephine has supported the pharmaceutical industry for over 18 years and will continue supporting the industry offering its services which include:
GCP/GCLP auditing and consultancy:
Rephine provides a comprehensive GCP/GCLP consultancy service to ensure that clinical trials are conducted in compliance with the ICH E6 regulations. Rephine is a consultancy providing a wide range of clinical and regulatory services to CROs and the pharmaceutical, medical device and biotechnology industries worldwide http://rephine.com/gcp/gcpgclp-training/.
GMP auditing and Rephine’s Audit library:
Rephine frequently performs audits at a number of supplier sites around the world. Rephine carry out full site audits which focus on the facility’s quality management systems and cover a large number of products. With the express permission of the supplier, Rephine adds the audit report to the Rephine report library and it can then be purchased by Rephine’s clients. By purchasing a GMP audit report, Rephine’s clients only incur a small fraction of the costs usually associated with conducting a supplier audit http://rephine.com/gmp/audits/reports/.
Readability Testing (PILs):
Rephine conducts readability testing of patient information leaflets (PILs) for clients in an interview process. The methods for these tests developed, validated and standardised by Rephine guarantee reliable, and most importantly, fast results for medicinal products in the last phase of the marketing authorisation procedure http://rephine.com/regulatory/readability-testing-pils/.
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Last updated on: 12/10/2016
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