Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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We have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GMP compliance systems
The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives.
Improving both product and process understanding, in combination with quality risk management, will support the establishment of an appropriate control strategy for consistent product quality and improved process performance
The fundamental GMP requirement for demonstrating adequate process control and the ability to manufacture reproducible product with the established quality.
Rephine’s wide experience working both with pharmaceutical laboratories and directly with the main actors involved in the supply chain, allows us to address different risk management strategies and to easily respond to issues.
Our experience in GCP and GVP has supported clients in the changing pharmaceutical industry. Many companies are constantly filing drug applications for new medicines and new markets for existing medicines
We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.
Article The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …
Blog EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …
Article Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity. …
Blog An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …
Article Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …
Article Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …
Blog Bringing rigour to global supply chains as the reinvention of medicine continues by: Dr. Eduard Cayon, VP Audit Services, Rephine New waves of innovation in …
Ebook About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …
Telephone:
Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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