10/11/2022
Founded in 1998, Rephine is a multinational audit and company that supports the industry, focusing on and compliance, as well as regulatory matters. Headquarters are based in Stevenage, UK, with branch associates in India, Germany, Poland, France, Spain and Italy.
Rephine’s core business is its library of Audit Reports which are available for customers to purchase instead of conducting their own audits at suppliers. The library includes more than 200 GMP , covering 7,390 individual products, which makes Rephine the largest provider of third-party 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 of choice for quality matters in the development and manufacture of products.
Supporting research and development of new products, Rephine provides a comprehensive range of and services, such as:
• : CRO/Vendor Selection, Audit Programme Development, QMS Development etc.
• GxP Training and Coaching ( , , , etc.)
• and Management Training
• Facility Audits (Laboratory, Clinical Unit, IMP Depot, Archiving Facility etc.)
• Vendor Audits (CRO, IT Solution Vendor, CTSL Vendor, PV Vendor etc.)
• System Audits (CSV, QMS, Data Management, Records Management etc.)
• Project Audits (BA/BE, Phase I-IV, (e)TMF, Clinical Database etc.)
• BA/BE Study Management and Monitoring
• GxP Inspection Preparation (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.
Mail: [email protected]