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Nirav Shah Email
Regional Director . Rephine
Stevenage,
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Founded in 1998, Rephine is a global and independent audit and consultancy company supporting the pharma industry in achieving compliance with all applicable Good Practices (GxP). Headquarters are based in Stevenage, UK, with branch associates in India, Turkey, Germany, Poland, France, Spain and Italy. 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. Rephine supports the clinical and preclinical research with QA consultancy, GxP training and execution of complete auditing programmes that include: • Facility Audits (such as Clinical Units, Investigator Sites, Laboratories or IMP Depots etc.) • Vendor and Partner Audits (such as CROs, Clinical Supply Logistics Vendor, IT Solution Vendors or Pharmacovigilance Vendors/Affiliates/Business Partners etc.) • Process and System Audits (such as Computerised Systems, Quality Management Systems (QMS), Data Management and Biostatistics or Records Management Systems etc.) • Project Specific Audits (such as Document Audits, TMF/eTMF Audits, Phase I-IV Study Audits or Clinical Database Audits etc.) • Inspection Readiness Audits and Mock Inspections 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.Rephine Address
15 Meadway Court, Rutherford CloseStevenage, null