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During the pandemic, we applied an agile approach to maintaining highest standards, harnessing the latest tools and techniques to conduct virtual audits as a temporary measure at times when physical inspections were not possible. We now harness those same techniques as an invaluable supplement to on-site inspections, allowing us to focus our face-to-face time where it is needed most.
We conduct rigorous audits of pharma manufacturers across the supply chain, to ensure strict GMP standards are being met – fulfilling applicable regulations and ensuring patient safety.
Rephine’s methodology ensures total impartiality and confidentiality during the whole audit process.
Our deeply-experienced Regulatory experts can provide help right across the regulatory lifecycle, to ensure that dossiers are up to scratch pre-, during, and post-submission.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Blog From repeatable rigour and experienced expertise, to highly ethical and transparent practices Alasdair Leckie, VP Audit Services, Rephine As in any other area of life …
Pharmaoffer, the ‘Amazon’ of API suppliers, will link its customers to Rephine’s vast library of live, off-the-shelf GMP audit reports of manufacturers around the world …
Article Live online event to be held on April 17th-18th 2023 and will feature deep domain expertise within the scope of Quality Assurance. Stevenage, Hertfordshire, 27th …
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 …
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