Rephine

Tim Hawkins Joins Rephine as CEO to Spearhead Global Expansion! Rephine is thrilled to welcome Tim Hawkins as our new CEO! 🎉 With over 20 years of experience in the pharmaceutical and healthcare sectors, Tim's leadership will drive Rephine’s next phase of global growth and elevate our mission of providing top-tier GMP audit and consulting services. Tim’s proven track record at McKinsey, Elsevier, and most recently BioPhorum, where he led global expansion efforts, perfectly aligns with Rephine’s commitment to quality assurance and supply chain compliance for the pharmaceutical, biotech, and medical device industries. Tim shared:   "I’m excited to lead Rephine and continue its legacy of excellence in GMP auditing and advisory services. Together, we’ll push new boundaries in supply chain assurance for our clients worldwide!" Join us in celebrating this exciting new chapter at Rephine. 🚀 Read more about Tim’s appointment and our plans for the future here 🔗 (https://lnkd.in/eyjwJC2w). #Leadership #PharmaExcellence #GlobalGrowth #GMP #QualityAssurance #SupplyChainCompliance #Rephine #CEOAnnouncement #Team_Rephine

We're #hiring a new Lead CSV Specialist for Pharma Consulting-Multi-Project & Client-Focused Role (ERP, SAP) in Barcelona, Catalonia. Apply today or share this post with your network.

Preparing for FDA Inspections: Why Mock Inspections Are Essential for OTC Products 💊 With the FDA increasing scrutiny on manufacturers of over-the-counter (OTC) drug products, it's more important than ever to ensure your plant is fully prepared for regulatory inspections. A mock inspection can be the key to identifying compliance gaps before the FDA comes knocking. At Rephine, we simulate FDA inspections to evaluate your processes, quality systems, and operations, helping you develop an action plan to meet US regulatory requirements. 💡 Our experienced consultants provide targeted insights that pave the way for success in the US market. 📝 Key Areas of Focus in Mock Inspections: - Quality systems - Facilities & equipment - Production processes - Materials management - Packaging & labelling ✅ Read our latest blog to learn how Rephine's mock inspections can ensure your company is ready for FDA compliance. Explore our case study on a recent client success in navigating the OTC market. https://lnkd.in/e5P2Gs5A 📩 Contact us today to schedule a mock inspection and ensure your plant is FDA-ready! enquiries@rephine.com #FDACompliance #OTCProducts #MockInspections #Pharma #QualityAssurance #RegulatoryAffairs #GMP #Rephine #PharmaceuticalIndustry #RegulatoryCompliance #CGMP

Rephine is Attending MEDICA - Leading International Trade Fair 2024 📅 Save the Date! 🗓 11th–14th November 📍 Düsseldorf, Germany We’re excited to announce that the Rephine MedTech team will be attending Medica 2024! 🚀 Our medical device compliance experts will be on hand to discuss how we can help you navigate the complexities of MDR/IVDR, regulatory submissions, QMS implementation, and more. 🙋♀️ Silvia Vilches Saez 🙋♀️ Anna Jordà Coll 🙋♂️ Jorge Kucharski Teotino This is a fantastic opportunity to meet our specialists in person and explore tailored solutions for your medical device compliance needs. 💬 Book a meeting with us at the show and let’s talk about how we can support your regulatory journey. 🔗 enquiries@rephine.com Looking forward to seeing you there! #Medica2024 #MedicalDevices #MDR #Compliance #MedTech #RegulatoryAffairs #QMS

📢 Urgent Need for MDR/IVDR Revisions 🏥 On October 23, 2024, the European Parliament passed a resolution calling for an urgent review of the Medical Devices Regulations (MDR & IVDR). The Parliament acknowledged the significant improvements these regulations have brought to the safety and quality of medical devices. However, they also stressed the 𝗻𝗲𝗲𝗱 𝗳𝗼𝗿 𝗶𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲 𝗮𝗰𝘁𝗶𝗼𝗻 𝘁𝗼 𝗮𝗱𝗱𝗿𝗲𝘀𝘀 𝗱𝗲𝗹𝗮𝘆𝘀 𝗮𝗻𝗱 𝗯𝗼𝘁𝘁𝗹𝗲𝗻𝗲𝗰𝗸𝘀 𝘁𝗵𝗮𝘁 𝗮𝗿𝗲 𝗰𝘂𝗿𝗿𝗲𝗻𝘁𝗹𝘆 𝗹𝗶𝗺𝗶𝘁𝗶𝗻𝗴 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝘃𝗶𝘁𝗮𝗹 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀. 𝗞𝗲𝘆 𝗽𝗿𝗶𝗼𝗿𝗶𝘁𝗶𝗲𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: • Resolving issues of divergent interpretation and streamlining the regulatory process. • Improving transparency and reducing the bureaucratic burden for notified bodies and manufacturers, particularly SMEs. • Expediting certification without compromising patient safety. The European Parliament urged the European Commission to implement reforms to ease certification challenges while maintaining patient safety and access to innovative medical devices. 𝗧𝗵𝗲𝘀𝗲 𝗿𝗲𝘃𝗶𝘀𝗶𝗼𝗻𝘀 𝗮𝗿𝗲 𝗲𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝘁𝗼 𝗱𝗿𝗶𝘃𝗲 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝗯𝗲𝘁𝘁𝗲𝗿 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗮𝗰𝗿𝗼𝘀𝘀 𝘁𝗵𝗲 𝗘𝗨. 📄 For full details, check out the resolution here: [2024/2849(RSP)](https://lnkd.in/epZipk2V) 🔔 Stay informed and explore the latest MedTech regulatory updates directly from: [Rephine MedTech EU Regulatory Updates] https://lnkd.in/dU68xwhr #MedicalDevices #Regulation #HealthcareInnovation #EU #RephineMedTech

We're #hiring a new German Sales Account Manager in United Kingdom. Apply today or share this post with your network.

We're #hiring a new Computer System Validation Consultant in Barcelona, Catalonia. Apply today or share this post with your network.

🌐 Maintaining Cloud Systems: A Continuous Effort 🌐 Cloud adoption is on the rise, but for GxP-regulated industries, ensuring compliance and managing updates can be challenging. From handling provider dependencies to maintaining robust incident management, successful cloud maintenance requires careful planning and execution. 💡 Download our latest guide to uncover key strategies for: Managing frequent updates Incident handling and change control Ensuring continuous compliance 👉 Find out more and download the guide here: Maintaining Cloud Systems: A Continuous Effort https://lnkd.in/eEadxMmW Have any questions? Our digitalisation experts at Rephine are ready to help! enquiries@rephine.com #CloudMaintenance #Compliance #DigitalTransformation #GxP #Digitalisation #Pharma #Rephine

📋 Streamline Your Audit Management with Rephine Connect In today’s fast-paced pharmaceutical landscape, audit efficiency is essential. With increasing regulatory pressures and the need for continuous compliance, staying on top of your audit requirements can feel overwhelming. That’s where Rephine Connect comes in! ✨ Our all-in-one platform revolutionises audit management by giving you full visibility and control over your audits—from planning to execution, and everything in between. ✅ Why Does Efficient Audit Management Matter? Reduced Risks: Stay compliant by effectively managing your audit schedule and outcomes. Cost Savings: Eliminate unnecessary costs by streamlining processes and reducing audit duplication. Time Efficiency: Automate repetitive tasks and focus on higher-value activities. Customisable & Scalable: Tailor the platform to your organisation’s specific needs, whether you're managing a few audits or hundreds. Discover how Rephine Connect can help you simplify audit workflows, improve collaboration, and ensure consistent regulatory compliance. 👉 Learn more at: https://lnkd.in/eKWBQuSe #RephineConnect #AuditManagement #PharmaCompliance #DigitalTransformation #PharmaIndustry #RegulatoryAffairs #GMP #GxP

🔍 Understanding General Safety and Performance Requirements (GSPRs) for Medical Devices 🔍 The General Safety and Performance Requirements (GSPRs) are a crucial set of over 20 requirements found in Annex I of Regulation EU 2017/745 (MDR) and 2017/746 (IVDR). These requirements are essential to ensure that medical devices meet the standards for safety and performance. They are structured into three main chapters: 📌 Chapter I: General Requirements 📌 Chapter II: Design and Manufacturing Requirements 📌 Chapter III: Information Accompanying the Device 🔑 GSPRs are the keystone for achieving conformity with medical device regulations in Europe. According to Annex II (Clause 4) of the MDR/IVDR, all manufacturers aiming to place their devices on the European market must follow these steps: 1️ Compile a list of all GSPRs and determine which apply to their device, providing proper justification in each case. 2️ Define common specifications (CS), harmonised standards, or other solutions to be used to comply with each GSPR. 3️ Describe the methods and gather evidence to demonstrate conformity with each applicable GSPR, ensuring across-reference to the location of this evidence within the device Technical Documentation is included. ⚠️ Failure to properly address GSPRs can prevent you from obtaining CE marking for your device. At Rephine, we can assist you in ensuring compliance by: ✔️ Identifying applicable GSPRs for your devices. ✔️ Selecting the appropriate CS, standards, and other guidance documents. ✔️ Defining the necessary reports from your Technical Documentation to provide evidence of compliance. 👁️🗨️ Take a look at our handy Essentials Guide on EU GSPR Compliance for Medical Devices https://lnkd.in/ekc2E3QH 👉 Need help navigating GSPR requirements? Contact us to ensure your device is fully compliant! enquiries@rephine.com #MedicalDevices #Regulations #GSPR #MDR #IVDR #Compliance #CEMarking #Rephine