Rephine Limited

About Rephine Limited

Rephine is a consultancy providing specialised GxP compliance services and regulatory support to the pharma, biopharma and medtech industries worldwide

Rephine is a leader in GMP auditing and has a library of over 250 GMP audit reports of suppliers that can be provided to their customers.

Rephine provides a comprehensive GCP/GCLP consultancy and auditing services to ensure that clinical trials are conducted in compliance with all the applicable regulations.

Rephine’s regulatory consultancy provides a complete portfolio of regulatory services to the pharmaceutical industry from clinical trial regulatory support to product life cycle management.

Rephine also operates RephineSourcing.com, an innovative service specifically designed for API-sourcing, global business development and documentation management update.

  • GB
  • 2017
    On CPhI since
  • 1
    Certificates
  • 50 - 99
    Employees
Consultancy
Contract Service
Contact info

Products from Rephine Limited

  • Rephine’s GMP Audit Reports

    Product Rephine’s GMP Audit Reports

    Rephine provides personalised, detailed and comprehensive GMP audit reports that are recognised and accepted by QPs and regulatory authorities around the world. The Rephine list of audit reports is updated regularly.

    If the audit you require is not on the list, you can review the Rephine Audit Planning Service or contact us to find out whether it is in the programme to be done or how it can be fitted in to the programme in the future.

  • Commissioned GMP Audits

    Product Commissioned GMP Audits

    Rephine’s commissioned audit service gives our customers the opportunity to work with us to design exclusive audits tailored to the specifics of their operations. Customers can commission various audits including:

    -API Manufacture-Excipient Manufacture
    -Investigational Medicinal Product (IMP) Manufacture
    -All forms of Secondary Manufacture
    -Contract Packaging Organisations
    -Contract Manufacturing Organisations


  • Good Clinical Practice (GCP) auditing services

    Product Good Clinical Practice (GCP) auditing services

    Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
    Rephine’s portfolio of GCP services include:
    - 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
    - Pre-Approval Investigator Site Audits
    - Quality Management Consultancy
  • Regulatory Affairs Support Services

    Product Regulatory Affairs Support Services

    Rephine’s regulatory consultancy provides a complete portfolio of regulatory services to the pharmaceutical industry from clinical trial regulatory support to product life cycle management. Services include but are not limited to full clinical trial application (CTA) support, full marketing authorisation (MA) support, eCTD dossier preparation and regulatory strategy consultation specific to the clients’ needs.

Rephine Limited Resources