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Rephine performs various GMP audits including Active Pharmaceutical Ingredients (APIs) and Intermediates to ICH Q7 and ICH Q9 standards, as well as excipient, packaging and various other audits.
Rephine provides a comprehensive GCP/GCLP consultancy service to ensure that the clinical trials are conducted in compliance with the ICH E6 regulations.
Rephine's portfolio of Regulatory services includes Marketing Authorisations, Product Compliance, Patient Information Leaflets and Regulatory Inspections.
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.