Rephine

Rephine

Pharmaceutical Manufacturing

Stevenage, Hertfordshire 8,811 followers

Worldwide GMP Auditing, Consulting and Regulatory Services Leader.

About us

Global experts in quality assurance & GxP compliance across pharmaceutical, biotech & medical device manufacturing supply chains Who is Rephine? We are deeply experienced GxP consultants, auditors and practitioners. We proactively help pharmaceutical and medical device companies around the world with all aspects of their manufacturing and supply chain quality assurance and associated business process optimisation. We have been providing these specialist quality assurance services for more than 25 years. With our honed processes, bespoke service design, appropriate use of technology, and audit report consistency, we have established an enviable reputation and are widely acknowledged to be the Gold Standard in our field.

Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Headquarters
Stevenage, Hertfordshire
Type
Public Company
Founded
1998
Specialties
GMP Auditing, Quality Assurance, Regulatory Compliance, Third party audits, vendor audits, supplier audits, API audit, ICH Q7 audit, audit reports, GMP compliance, gap analysis, remediation, QMS development, bespoke audits, pre-submission review, submission support, and post-submission lifecycle management

Locations

Employees at Rephine

Updates

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    8,811 followers

    🌟 Meet Rephine’s Consulting Experts at CPHI Milan 2024! 🌟 We are proud to announce that Rephine’s top consulting experts will be at CPHI Milan 2024 and ready to share their deep knowledge and insights with you! Join us at Stand 2F41 in the API Zone to engage with our experienced team and get tailored advice on your most pressing challenges. 👥 Meet Our Experts: - Dr. Eduard Cayón, Chief Scientific Officer   - Marian San, VP Consulting   - Jorge Kucharski, Consulting BDM   - Víctor Samitier, QMS Consulting Line Director  🔑 These thought leaders will be on hand to provide expert guidance on: - GxP Consulting: Navigating Good Practice regulations to ensure compliance. - Digitalisation: Embrace cutting-edge solutions to boost efficiency and innovation. - Quality Management Systems (QMS): Build robust, compliant, and scalable quality systems. Whether you’re looking to stay compliant, streamline operations, or explore new ways to innovate, our team is here to help. Don’t miss this chance to discuss your business needs with industry experts! 📅 Save the Date: 8th - 10th October 2024   📍 Location: Fiera Milano, Milan   📍 Stand: 2F41, API Zone Come and connect with the Rephine team—we look forward to seeing you there! #CPHIMilan2024 #Rephine #GxPConsulting #Digitalisation #QMS #PharmaExperts #NetworkingOpportunity #SaveTheDate #PharmaInnovation #MeetTheExperts

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    8,811 followers

    🌟 Why Pharma Companies Can’t Miss the Rephine Stand at CPHI Milan 2024! 🌟 With CPHI Milan 2024 fast approaching, we’re excited to share why visiting Rephine at stand 2F41 in the API Zone is a must for pharma professionals looking to stay ahead in the industry. Here’s why you should stop by: 🔑 Exclusive Insights: Our experts will be available to share valuable knowledge on: - Audit Management: Discover new features to streamline and optimise your audit processes. - Digital Transformation: Learn how our digital solutions can revolutionise your compliance and operational efficiency. - GMP, QMS, GxP, Medical Device expertise and much more! 🤝 Networking Opportunities: CPHI Milan is a global hub for pharma leaders, and our stand is the perfect place to connect! Meet our experienced team, discuss industry challenges, and explore potential collaborations that drive business success. Whether you're looking to enhance compliance, improve processes, or embrace innovation, Rephine is ready to support your journey. 📅 Save the Date: 8th - 10th October 2024   📍 Location: Fiera Milano, Milan   📍 Stand: 2F41, API Zone Don’t miss out— book a meeting with our experts now! enquiries@rephine.com #CPHIMilan2024 #Rephine #PharmaInnovation #AuditManagement #DigitalTransformation #GMPCompliance #NetworkingOpportunity #PharmaExperts #SaveTheDate

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    🚨 Rephine’s Upcoming Audits – Plan Your 2024 Now! We’re excited to share our audit schedule for the next 3 months, with available slots that could fit perfectly into your audit plans! 🌍 📅 What’s next? - Explore our upcoming audit sites. - Let us help you focus on your product of interest. - Acquire detailed, product-specific reports to fine-tune your 2024 audit strategy. 🔗 Ready to streamline your audits? Discover Rephine’s 2024 Audit Plan https://lnkd.in/djgBwnWD #Pharma #Audits #SupplyChain #Compliance #QualityAssurance #AuditPlanning

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    8,811 followers

    ⚙ Transforming Validation Processes with ValGenesis 5.0 and Rephine’s Expertise We understand that in today's rapidly evolving life sciences industry, maintaining compliance and data integrity while streamlining validation processes is crucial. That’s why we are excited about the advancements introduced with ValGenesis VLMS 5.0, a cutting-edge digital validation lifecycle management system. Why ValGenesis 5.0?  ValGenesis 5.0 is a game-changer, offering an intuitive, user-centric interface designed to boost efficiency and ensure compliance. With enhanced automation capabilities, real-time collaboration, and robust analytics, this latest version simplifies the complexity of validation processes across your organisation. The result? Reduced time and costs, fewer manual errors, and a seamless path to regulatory compliance. How Rephine Can Help  At Rephine, our deep expertise in computer systems validation (CSV) and commitment to ensuring data integrity means we are perfectly positioned to guide your transition to a fully digital validation environment. Our partnership with ValGenesis allows us to tailor the implementation of VLMS 5.0 to your specific needs, ensuring that your validation processes are not only compliant but also optimised for maximum efficiency. Key Benefits of Partnering with Rephine: - Expertise in CSV: Our consultants bring years of experience in implementing and validating GxP-compliant systems, ensuring that your operations meet the highest regulatory standards. - Ensured Data Integrity: We help you maintain impeccable data integrity throughout the validation lifecycle, safeguarding your critical business data. - Streamlined Implementation: We manage the entire implementation process, from planning to execution, ensuring a smooth transition with minimal disruption to your operations. Embrace the future of digital validation with ValGenesis 5.0, and let Rephine be your trusted partner in achieving compliance excellence. Get in touch with our Digital Validation experts https://lnkd.in/eCfiFCHf #DigitalTransformation #Validation #GxPCompliance #DataIntegrity #Rephine #ValGenesis #Pharmaceuticals #Biotech

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    8,811 followers

    🔍 Enhance Your Audit Planning with Rephine Connect 🔍 Rephine is pleased to introduce a new level of efficiency in audit management with Rephine Connect—a powerful tool designed to streamline your audit processes and keep you fully connected. ✨ Key Enhancements: - Access Our Audit Calendar: You can now view our audit schedule directly through the Rephine Connect portal. No need to contact us to check dates—simply log in, review available audits, and request to join as a sponsor with ease. - User-Friendly Interface: Navigate the platform effortlessly, with all necessary information at your fingertips. - Comprehensive Tools: Manage CAPAs, share critical information, and track audits seamlessly in one centralised location. 💡 Why Choose Rephine Connect? Rephine Connect centralises your audit planning, providing a clear overview of our audit schedule and streamlining the entire process. By having all the information you need in one place, you can plan more effectively and efficiently, ensuring that your audit processes are both comprehensive and convenient. Discover how Rephine Connect can elevate your audit management strategy. https://lnkd.in/eKWBQuSe #AuditManagement #RephineConnect #PharmaAudits #Compliance #Efficiency #AuditPlanning

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    In today's rapidly evolving pharmaceutical landscape, AI is transforming quality assurance by enhancing precision, efficiency, and compliance. At Rephine, we leverage AI-driven solutions to ensure GxP compliance, improve audit readiness, and optimize quality management systems. By integrating advanced AI techniques with our deep industry expertise, we help organizations navigate the complexities of regulatory requirements, minimize risks, and drive continuous improvement. Partner with Rephine to stay ahead in the age of AI and ensure your quality assurance processes are both innovative and compliant. #QualityAssurance #AI #GxP #Pharmaceuticals #Compliance #Rephine For more insights, explore our resources 👇 https://lnkd.in/e4JNbCbn

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    The Critical Advantage of Scheduling GMP Audits in Advance In today's fast-paced pharmaceutical landscape, ensuring compliance with Good Manufacturing Practice (GMP) regulations is more crucial than ever. But when it comes to audits, waiting until the last minute can lead to unnecessary stress, missed deadlines, and potential compliance risks. That’s why scheduling your GMP audits ahead of time is not just a good practice—it’s a strategic advantage. At Rephine, we recognise the importance of forward planning. By scheduling your audits early, you can ensure your products are included in the scope of the audit. This means you can streamline your audit process, reducing the time and resources spent on arranging individual audits, and instead focus on ensuring that your manufacturing partners are consistently meeting regulatory standards. 🔑 Key Benefits of Scheduling GMP Audits with Rephine:** 1. Comprehensive Coverage: With our extensive global audit library, you’re more likely to find an existing audit that matches your needs, saving time and money. 2. Risk Mitigation: Early scheduling allows for better preparation, reducing the risk of non-compliance and ensuring that you meet all regulatory requirements without last-minute pressure. 3. Efficiency and Expertise: Our team of experienced auditors can provide valuable insights and recommendations, helping you maintain high standards across your supply chain. 4. Flexibility: Advanced planning gives you the flexibility to choose audit dates that fit seamlessly into your operational schedule, avoiding disruptions. Don't let compliance challenges catch you off guard. Secure your audits in advance with Rephine and leverage our unparalleled resources to maintain the highest GMP standards with confidence. 👉 Discover more about our GMP audit services and explore our global audit library here: https://lnkd.in/etM_3kQY #GMPCompliance #PharmaceuticalAudits #QualityAssurance #RegulatoryAffairs #SupplyChainManagement #RephineAuditServices #PharmaIndustry #GMP

    Third Party Audits - Rephine

    Third Party Audits - Rephine

    rephine.com

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    8,811 followers

    🌍 Global Reach with Local Expertise: Elevating Pharma Manufacturing Audits 🏆 At Rephine, we understand that successful audits go beyond ticking boxes—they require a deep understanding of both global standards and local nuances. With dedicated account managers across Europe, India, and China, we ensure seamless communication and tailored support for our clients, no matter where they are. Our local auditor teams bring invaluable insights into the unique cultural and regulatory landscapes of each region, ensuring that every audit is not only compliant but also conducted with the highest level of integrity and excellence. 💡 Why Choose Rephine? - Global Network, Local Expertise: Our auditors and account managers are strategically located across key regions, combining global best practices with in-depth local knowledge. - Cultural and Regulatory Understanding: We help you navigate complex regulatory environments with ease, ensuring confidence in the audit process. - Gold Standard Audits: Our audits set the benchmark for quality and reliability, giving you peace of mind and the assurance that your operations meet the highest global standards. Partner with Rephine and experience the difference that our unique blend of global reach and local understanding can make for your pharmaceutical manufacturing processes. Find out more here https://lnkd.in/d-sudhU5 #Pharma #GMP #GlobalCompliance #QualityAssurance #Pharmaceuticals #AuditingExcellence

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