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About CCRA

Rephine Ltd
15 Meadway Court
Rutherford Close
Stevenage, Hertfordshire
United Kingdom

Tel: 01763 853135
Fax: 01763 853573

Web: www.rephine.com

Rephine is a global pharmaceutical consultancy founded in 1998 that focuses on GCP and GMP compliance, as well as regulatory matters. Rephine has an extensive library of over 170 GxP audit reports that covers 7,390 individual products which makes Rephine the largest provider of third-party GxP audit reports in Europe.

In addition to this Rephine provides a comprehensive GCP/GcLP consultancy, auditing and training services including but not limited to:

  • Investigator Site Audits
  • Phase I Facilities and Study Audits
  • Inspection Readiness and Mock Inspections
  • Auditing of Essential Documents (TMF)
  • GcLP Audits
  • Computer System Validation
  • Archive Facility Audits
  • Quality Management Consultancy
  • Due Diligence
  • GCP/GcLP Training

Rephine GXP consultants are a global group of highly professional and experienced personnel who have worked with multinational pharmaceutical organisations and CROs able to provide outstanding GCP and GMP service at very competitive price schemes.

Furthermore Rephine has started a GCP Qualification Programme specially developed to assist sponsors when assessing a Contract Research Organisations.

Companies who would like to join the GCP Qualification Programme, must meet the Rephine quality criteria and pass the Rephine Qualification Audit to a satisfactory standard. This is a very comprehensive and detailed audit carried out by an independent assessor/s. The audit report will give an accurate overview of the company’s operations and its GCP compliance status and will help companies to meet the GCP regulatory requirements.

Group sector
  • GCP Inspection Readiness and Mock Inspections (EMA, FDA, MHRA, BfArM, ANSM, Health Canada, Danish Inspectorate, Anvisa, Local German Federal Authorities)
  • CRO qualification audits (facilities, project management, clinical operations, clinical monitoring, data management, biostatistics, regulatory affairs, medical monitoring, medical writing, clinical facilities, QA programme, training, IT systems and CSV, deviation management, inspection history, archiving)
  • Investigational Site audits
  • Computer Systems Validation
  • TMF audits (phase I to phase IV)
  • Bioanalytical study (PK/PD) audits
  • Data Management/Biostatistics Systems audits
  • GMP
  • GDP
  • Due Diligence
  • Gap Analysis

Geographical area

  • Worldwide

For further information, please contact:
Dr Rino Coladangelo MB BS MRCP, CEO
Viktoria Angelova, BSc, MSc, Business Development Executive

CCRA is a not-for-profit organisation originally founded to represent independent clinical research contractors and allied industries.