Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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Nowadays, many companies must face new challenges and situations that arise from new business opportunities: the development of a new product, the opening of new markets in new countries or geographical areas, agreements with international companies for a project on a global scale… This results in the need to comply with new or different regulations, not previously considered.
Opening to other markets, either in Europe, USA, Asia-Pacific, the Middle East or Latin America, requires the need of compliance to high standards of cGMP and the success in the subsequent inspections, a pre-requisite for the approval of new activities or products.
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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
After a rigorous process for becoming certified by Sparta, we have a powerful and experienced team to implement TrackWise systems according of each client’s requirements. These requirements are captured through different workshops and subsequent prototypes are made.
After a rigorous process for becoming certified by Sparta, we have a powerful and experienced team to implement TrackWise systems according of each client’s requirements. These requirements are captured through different workshops and subsequent prototypes are made.
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