Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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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 and regulatory services to help keep our clients ahead of the needs and expectations of regulators.
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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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