Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
Menu
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.
From initial dossier review and gap analysis, to hands-on help with eCTD submissions, to longer-term variation management, we’ll help you accelerate market delivery and maintain ongoing compliance.
We can provide these services for both drug substances and for finished drug products.
We’ll review your dossier and provide a detailed gap analysis so that you can ensure your submissions are successful first time.
Our experts can help you fill any gaps, draft content as needed, and submit the finished dossier to the relevant agencies in the correct eCTD format.
We’ll help you maintain compliance on an ongoing basis, ensuring robust variations management and continuous tracking of evolving authority requirements.
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
Sign up to our newsletter to get the latest news about Rephine and industry news.