Rephine Ltd. is a consultancy that provides a wide range of clinical and regulatory services to the pharmaceutical, medical device and biotechnology industry worldwide. Rephine’s main objective is to support organisations in producing products that meet the highest Health & Safety and Quality standards.
Rephine has collaborated with manufacturers in most parts of the world and our knowledge of EU requirements is exceptional. Rephine is a specialist provider of GxPractice (GxP) services including Good Manufacturing Practices (GMP) and Good Clinical Practice (GCP) services.
Rephine’s Consultants are all very experienced and highly qualified scientists who have worked extensively in the industry. Rephine’s consultancy services include GAP Analysis, Due Diligence, Crisis Avoidance, API Sourcing, Training and QP services.
Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP/GCLP 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/GCLP services include:
Investigator Site Audits
Phase I Facilities and Study Audits
Inspection Readiness and Mock Inspections
Auditing of Essential Documents (TMF)
Computer System Validation
Archive Facility Audits
Pre- Approval Investigator Site Audits
Quality Management Consultancy
By employing an independent, third party auditing company like Rephine, the audit sponsor can ensure that the results of the audit are impartial, thereby establishing credibility. A third party organisation also minimises the costs associated with having an in-house auditing department.
Rephine services can be of interest to
Medical device producers
Service companies (CROs)
Rephine’s Auditing Services can be designed for your particular project needs and budget, bringing a high level of process assessment and improvement to your clinical trial, site and/or systems.