Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
Our comprehensive suite of Quality Assurance services includes mock inspections, equipment qualification/computerised system validation, and plant engineering assessments.
We have a team of international consultants with extensive knowledge of the technologies and computer systems used in the pharmaceutical industry.
We offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems
TrackWise® created by Sparta Systems, is the most trusted Enterprise Quality Management System (EQMS).
Rephine provides innovative and scalable solutions to meet the quality and compliance requirements of the Medical Devices sector
Our experience in the qualification and commissioning of facilities and equipment is backed by years of successful inspections and audits
We have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GMP compliance systems:
Rephine offer our customers training sessions in different formats: in person and also online
We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.
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, …
EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …
Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity. …
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 …
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. …
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 …
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 …
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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