Rephine
Rephine is a global leader in life sciences quality assurance and GxP compliance, serving pharmaceutical, biotech, and medical device manufacturing supply chains worldwide. With over 25 years of experience, Rephine offers comprehensive services including GMP auditing, GxP consultancy, regulatory support, and digital transformation to ensure product safety, compliance, and quality across the entire product lifecycle.
Industries
Nr. of Employees
small (1-50)
Rephine
Stevenage, Herefordshire, United Kingdom, Europe
Products
Audit report repository
Searchable library of audit reports and off-the-shelf audit evidence available to support supplier qualification and regulatory due diligence, with defined report validity and options to purchase access.
Audit lifecycle management portal
Cloud portal for managing audit programmes, document control, CAPA tracking and interactive analytics for multi-supplier or multi-site audit portfolios.
Audit report repository
Searchable library of audit reports and off-the-shelf audit evidence available to support supplier qualification and regulatory due diligence, with defined report validity and options to purchase access.
Audit lifecycle management portal
Cloud portal for managing audit programmes, document control, CAPA tracking and interactive analytics for multi-supplier or multi-site audit portfolios.
Services
Independent third-party audits covering QMS, facilities, manufacturing operations and supplier sites, with regulatory-grade audit reporting and custom audit scopes.
End-to-end GxP advisory including readiness assessments, gap analysis, remediation planning, QMS design and inspection preparation across the product lifecycle.
Vendor-neutral selection and validation of commercial quality and laboratory systems, full CSV lifecycle support and data integrity assurance for on-premise and cloud platforms.
Secure cloud portal for audit programme management delivering real-time audit tracking, centralised document and CAPA control, integrated communications and interactive analytics.
Regulatory consulting for medical devices and in‑vitro diagnostics including classification support, technical documentation compilation, and readiness for MDR/IVDR or equivalent regimes.
Support for auditees to streamline remediation workflows, implement CAPA plans and reduce internal resource burden following inspections or audits.
Independent third-party audits covering QMS, facilities, manufacturing operations and supplier sites, with regulatory-grade audit reporting and custom audit scopes.
End-to-end GxP advisory including readiness assessments, gap analysis, remediation planning, QMS design and inspection preparation across the product lifecycle.
Vendor-neutral selection and validation of commercial quality and laboratory systems, full CSV lifecycle support and data integrity assurance for on-premise and cloud platforms.
Secure cloud portal for audit programme management delivering real-time audit tracking, centralised document and CAPA control, integrated communications and interactive analytics.
Regulatory consulting for medical devices and in‑vitro diagnostics including classification support, technical documentation compilation, and readiness for MDR/IVDR or equivalent regimes.
Support for auditees to streamline remediation workflows, implement CAPA plans and reduce internal resource burden following inspections or audits.
Expertise Areas
- Third-party GMP auditing and supplier qualification
- Audit report library management and reuse with defined validity windows
- GxP readiness assessments, gap analysis and remediation planning
- QMS design, implementation and certification preparation
Key Technologies
- Cloud-based audit and CAPA management portals
- Electronic quality management systems (eQMS), LIMS and MES
- Computerised systems validation (CSV) methodologies
- Interactive analytics and dashboarding for audit data
News & Updates
Rephine's Chief Scientific Officer, Dr. Eduard Cayón, participated in a panel discussion on AI in Pharma Supply Chain, exploring innovative applications of AI and machine learning in the industry.
Rephine’s Dr. Eduard Cayón discussed key trends and priorities for drug manufacturers in 2024, including supply chain innovation and mRNA technologies.
Anna Cluet, Rephine’s GxP Expert, provided insights on the EU GMP Annex 1 updates and compliance strategies for sterile medicinal product manufacturing.
Rephine's Chief Scientific Officer, Dr. Eduard Cayón, participated in a panel discussion on AI in Pharma Supply Chain, exploring innovative applications of AI and machine learning in the industry.
Rephine’s Dr. Eduard Cayón discussed key trends and priorities for drug manufacturers in 2024, including supply chain innovation and mRNA technologies.
Anna Cluet, Rephine’s GxP Expert, provided insights on the EU GMP Annex 1 updates and compliance strategies for sterile medicinal product manufacturing.