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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 GxP compliance, as well as regulatory matters. Rephine has a GCP Library that offers third-party vendor assessment and audit reports of clinical CROs, Phase I Units, Laboratories and IT solution vendors. In addition to this, Rephine provides a comprehensive portfolio of GxP services, such as:

  • Consultancy: CRO/Vendor Selection, Audit Programme Development, QMS Development etc.
  • GxP Training and Coaching (GLP, GCP, GCLP, GVP etc.)
  • Clinical Research and Clinical Project 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 auditors have been selected for their long-standing experience in auditing, consultancy and heading the QA & Regulatory departments of the largest pharma companies and CROs. They provide outstanding service tailored around each customer’s needs at very competitive price schemes.

Rephine also supports sponsors of clinical trials with their regulatory requirements. Rephine can coordinate and manage all aspects of your clinical development program and provide the following Regulatory services:

Clinical Trial Regulatory Support

  • CTA Submission requirement consultation
    • Advise on the regulatory requirements for a successful submission of a robust clinical trial application dossier to the relevant regulatory authorities
    • EU Legal Representation
    • Guidance on the content of Study Protocols / Investigator Brochures (IB) / Investigational Medicinal Product Dossier (IMPD)
    • Ad-hoc consultancy regarding CMC
    • Advise on new regulations which may impact any stage of the clinical program
  • Preparation and management of Initial CTA to regulatory authorities
    • Preparation of technical Core Dossier
    • Creation of Country Specific CTA
    • Submission of CTA to regulatory and local authorities
    • Manage the regulatory aspects/timelines of the study and coordinate the regulatory submissions in the countries participating in the study
    • Interact with the RA and obtain the final decision
  • CTA Maintenance
    • Review the new / updated documentation and determine submission
    • Preparing and submitting non-substantial and substantial amendments to the CTA

Regulatory Consultancy

  • Study design consultation
  • High-level reviews of study and CMC documents, such as the protocol and the investigator’s brochure (IB) and Investigational Medicinal Product Dossier.
  • Scientific advice assistance – preparation for regulatory authority meetings (EMA Scientific Advice and protocol assistance)
  • Regulatory strategy for your clinical program specific to your product's needs, including use of the Voluntary Harmonisation Procedure (VHP)
Group sector
  • Pharmaceutical QA Consultancy
  • Clinical Trial Regulatory Support

Geographical area

  • Worldwide

For further information, please contact:
Dr Rino Coladangelo MB BS MRCP, CEO
Cristina Opran, MSc., BSc, GCP Services Manager
enquiries@rephine.com | 0044 1763 853135

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