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 excited to share our latest resource: Conceptual & Basic Design Review Guide: A Strategic Approach to GMP Compliance. This guide provides essential strategies for pharmaceutical professionals to optimise facility design, reduce contamination risks, and streamline qualification processes. 🔍 What’s inside?  - Key factors for assessing material flows and equipment layout - Techniques to minimise cross-contamination and meet GMP standards - Practical steps for reducing costs and improving project timelines Ensure your project’s success by addressing compliance from the earliest stages. Download the guide today and set your project up for GMP success! 📥 👉 Download the Guide Now https://lnkd.in/eBdhmJzv #GMPCompliance #PharmaManufacturing #DesignReview #PharmaGuidelines #GxP #RiskManagement #FacilityDesign #PharmaceuticalEngineering #Rephine #QualityManagement #LifeSciences

We're #hiring a new Medical Device Regulatory & Quality Consultant in Barcelona, Catalonia. Apply today or share this post with your network.

As we enter November, it's time to look back at the final important regulatory updates that shaped October. The Medical Device Coordination Group (MDCG) concluded a busy month by issuing two impactful guidance documents aimed at clarifying classifications and regulatory obligations for manufacturers: ⚠ "MDCG 2022-5 Rev.1: Guidance on the Borderline Between Medical Devices and Medicinal Products Under Regulation (EU) 2017/745" ⚠ "MDCG 2024-13: Regulatory Status of Ethylene Oxide (EtO) for Sterilizing Medical Devices." Key Takeaways from the October MDCG Guidance: 🔹 MDCG 2022-5 Rev.1: This document provides crucial guidance for manufacturers whose products fall on the borderline between medical devices and medicinal products. It addresses the primary intended purpose, mode of action, and product claims, along with specific examples to support accurate classification. This ensures compliance with the correct regulatory pathways and promotes patient safety—especially relevant for innovative products with overlapping characteristics. 🔹 MDCG 2024-13: This guidance clarifies the regulatory status of EtO when used in sterilizing medical devices, affirming that: EtO used in manufacturing processes for medical devices and in vitro diagnostics (IVDs) falls within the MDR and IVDR, rather than the Biocidal Products Regulation (BPR), due to exemptions outlined in Article 2(2)(b) of the BPR. EtO cartridges used by healthcare institutions for sterilizing devices (either pre-use or for re-use) are also regulated under the MDR as medical device accessories, thus outside the BPR’s scope. 📄 For full details, refer to the complete guidance documents: MDCG 2022-5 Rev. 1 https://lnkd.in/ewYq5Y4r MDCG 2024-13 https://lnkd.in/dA-d6RNt 🔔 Stay tuned with Rephine for more MedTech regulatory updates this November! https://lnkd.in/dU68xwhr #MedTech #MDR #IVDR #RegulatoryUpdates #Rephine

🌟 𝗣𝗹𝗮𝗻 𝗔𝗵𝗲𝗮𝗱 𝗳𝗼𝗿 𝟮𝟬𝟮𝟱 𝗔𝘂𝗱𝗶𝘁𝘀 𝘄𝗶𝘁𝗵 𝗥𝗲𝗽𝗵𝗶𝗻𝗲 𝗖𝗼𝗻𝗻𝗲𝗰𝘁! 🌟 With the new year fast approaching, now is the time to solidify your audit schedule for 2025. Proactive planning ensures a smooth audit process, reduces last-minute stress, and keeps you on track with compliance objectives. 🎯 𝗪𝗵𝘆 𝗖𝗵𝗼𝗼𝘀𝗲 𝗥𝗲𝗽𝗵𝗶𝗻𝗲 𝗖𝗼𝗻𝗻𝗲𝗰𝘁 𝗳𝗼𝗿 𝗔𝘂𝗱𝗶𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁? Rephine Connect is designed to streamline and simplify every stage of the audit journey, offering an organised platform for seamless audit scheduling, visibility on real-time status, and tools to manage documentation. With features like 𝗖𝗼𝗻𝗻𝗲𝗰𝘁 𝗪𝗶𝘀𝗵𝗹𝗶𝘀𝘁, Rephine Connect enables you to prioritise audits and track requirements effectively, helping ensure your team stays aligned and compliant. 📈 𝗞𝗲𝘆 𝗕𝗲𝗻𝗲𝗳𝗶𝘁𝘀 𝗼𝗳 𝗥𝗲𝗽𝗵𝗶𝗻𝗲 𝗖𝗼𝗻𝗻𝗲𝗰𝘁: - 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗢𝗿𝗴𝗮𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻: Easily manage audit schedules, documentation, and progress. - 𝗧𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆 & 𝗧𝗿𝗮𝗰𝗸𝗶𝗻𝗴: Real-time updates and audit history at your fingertips. - 𝗣𝗿𝗶𝗼𝗿𝗶𝘁𝗶𝘀𝗲𝗱 𝗔𝘂𝗱𝗶𝘁 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴: Use Connect Wishlist to focus on high-priority audits and manage compliance needs with ease. Get ahead with Rephine Connect and make 2025 your most productive year for audit management yet! 🚀 https://lnkd.in/eKWBQuSe #RephineConnect #AuditManagement #ComplianceSolutions #2025Planning #AuditScheduling #PharmaAudits #QualityAssurance #GMP #PharmaceuticalIndustry #DigitalTransformation

✨ Happy Diwali from all of us at Rephine! ✨ Diwali is a time of light, joy, and celebration, and our Rephine India team came together to mark this special festival with vibrant activities, delicious Indian food, and festive treats. It was a wonderful time to share stories, traditions, and, of course, some amazing snacks! At Rephine, we believe that celebrating cultural diversity brings us closer together, enriching our perspectives and strengthening our global team spirit. Every culture within Rephine adds to the shared knowledge, respect, and camaraderie that help us thrive. Wishing you all a Diwali filled with happiness, prosperity, and light! 🪔 #HappyDiwali #DiversityAndInclusion #Team_Rephine #RephineIndia

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