Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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We are always aiming the same target: to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product.
Project management for development/implantation of quality systems for new plants, processes and products.
Advice on the definition or optimization of the structure of the quality unit and the distribution of responsibilities.
Writing or updating quality system documentation: Policy, Quality Manual, Standard Operating Procedures (SOPs), etc.
Support and technical assistance in quality areas (Batch Review, Deviation and Layer Management, etc.)
Evaluation of regulatory and quality requirements applicable to each industry/process.
Quality System Internal Audits and Definition of the associated Action Plans.
Systems and Processes Risk Analysis.
GxP Compliance and Inspection Preparation
We strive to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product, considering the applicable regulatory requirements and national and international guidelines.
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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