Rephine

www.rephine.com

Rephine, 15 Meadway Court
Rutherford Close
Stevenage
SG1 2EF
United Kingdom

Activities

Summary

Founded in 1998, Rephine is a multinational audit and consultancy company that supports the pharmaceutical industry, focusing on GCP and GMP compliance, as well as regulatory matters. Headquarters are based in Stevenage, UK, with branch associates in India, Germany, Poland, France, Spain and Italy.

Profile

Rephine’s core business is its library of GMP Audit Reports which are available for customers to purchase instead of conducting their own audits at suppliers. The GMP library includes more than 200 GMP audit reports, covering 7,390 individual products, which makes Rephine the largest provider of third-party GMP audit reports in Europe.

Rephine services are provided on a global basis and have achieved a reputation for being of outstanding quality. The natural growth that has been seen in the company supports our aim to be the consultancy of choice for quality matters in the development and manufacture of pharmaceutical products. Supporting research and development of new medicinal products, Rephine provides a comprehensive range of GCP and GxP consultancy, auditing and training services, including but not limited to:

  • CRO and Vendor Qualification/Audit
  • Computer System Validation
  • Investigator Site Qualification/Audit
  • Phase I Unit Qualification/Audit
  • Phase I-IV In-Study Audit
  • Bioavailability and Bioequivalence Study Audit
  • GLP/GcLP Audits
  • Pharmacovigilance (GVP) Audits
  • GxP Inspection Readiness and Mock Inspections
  • TMF/e-TMF and Document (Protocol, IB, IMPD, CSR) Audit
  • System Audit and Process GAP Analysis
  • Quality Management System Consultancy
  • Due Diligence Audit

Rephine’s consultants are a global group of highly qualified experts, with at least 15-20 years’ experience in the pharmaceutical/clinical research industry, and at least half of these in auditing and quality assurance.

Having worked with some of the largest multinational drug/medical device producing companies and CROs, Rephine auditors are able to provide outstanding GCP and GMP services, meeting complex project requirements at very competitive price schemes.

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