#PharmaLexInTheField! 🚀🌍 This week, we’re excited to spotlight Bio Asia Taiwan Exhibition 2024! 🌟 🔹 Bio Asia Taiwan Exhibition 2024 | July 24-28, 2024 | Taipei City, Taiwan 🎙️ Speaker: Akiko Tsutsui 🔗 Learn more: https://lnkd.in/dtibi8Hu Akiko Tsutsui will be ready to connect and share insights during the event. For those interested in scheduling a virtual meeting, it will be accessible via the Virtual Partnering Platform. #PharmaLexInTheField #PharmaLex #Events #GlobalExpertise #NetworkingEvents
PharmaLex
Arzneimittelherstellung
Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains
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PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance, Pharmacovigilance, Epidemiology, and Risk Management worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. Through our worldwide offices, we provide flexible and cost-effective service models. Looking for local expertise with global reach? Contact us, to find out more!
- Website
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http://www.pharmalex.com
Externer Link zu PharmaLex
- Branche
- Arzneimittelherstellung
- Größe
- 1.001–5.000 Beschäftigte
- Hauptsitz
- Bad Homburg
- Art
- Privatunternehmen
- Gegründet
- 1994
- Spezialgebiete
- Regulatory Affairs, Pharmacovigilance, Regulatory Operations, Pharmaceutical Quality, Audit / Inspection Preparation, Medical Writing, Biostatistics, Medical Devices, Risk Mangement, Development Consulting, GxP services und Clinical Trial
Orte
Beschäftigte von PharmaLex
Updates
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We can help you navigate the regulatory complexities of combination products. While these products offer significant therapeutic benefits, they also introduce additional layers of regulatory challenges. They require harmonized regulatory strategies and meticulous alignment of manufacturing processes to meet diverse compliance standards. Are you confident in your product’s classification and regulatory approval strategy? Discover how PharmaLex can help you confidently navigate dual regulatory pathways across multiple jurisdictions. https://lnkd.in/gpVm8W2 #PharmaLex #CombinationProducts #DeviceLedCombinationProduct #RegulatoryAffairs
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Unlock the full potential of your Contamination Control Strategy (CCS) with insights from Noelle Clifford's latest article! Discover essential strategies for overcoming common hurdles, including: 🌟 The importance of a proactive Quality Risk Management (QRM) approach. 🌟 Steps to develop a comprehensive and centralized CCS. 🌟 The critical role of cross-functional teams and expert involvement. 🌟 Utilizing quantitative methodologies like FMEA for robust risk assessments. 🌟 Adhering to EU GMP Annex 1 to ensure product quality and safety. Read full article here: https://lnkd.in/dXCUMfBk #PharmaLex #ContaminationControl #QualityRiskManagement #GMPCompliance #Annex1 #QualityControl
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Streamlining regulatory processes globally is essential for timely access to medical innovations 🌍🧬 In her latest article, "Alleviating the Regulatory Burden Through the Access Consortium," Piety Rocha discusses how simultaneous assessment and approval timelines across borders can benefit the pharmaceutical industry. Discover how regulatory authorities are evolving to meet these needs. Read full article here: https://lnkd.in/da95jkeq #PharmaLex #RegulatoryAffairs #AccessConsortium #PharmaceuticalIndustry #MedicalDevices #DrugApproval
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🚨 On-Demand Webinar Alert! 🚨 Discover how new technologies are transforming pharmacovigilance and improving patient safety. Join our expert panel, hosted and moderated by PharmaLex, as they delve into the current state of pharmacovigilance technologies with real business use cases. 📅 Available On-Demand 🕒 1 hour 💻 Your Desk! Key learning objectives: 🔹 Transformative pharmacovigilance technologies: from automation to AI 🔹 Business use cases: outcomes and lessons learned 🔹 Evaluating technology projects: critical questions to ask 🔹 Future implications of AI for safety and clinical teams Don't miss this chance to learn how AI and other technologies can enhance your pharmacovigilance processes and boost patient safety. Watch now: https://lnkd.in/dNgmhFBP #PharmaLex #Pharmacovigilance #PatientSafety #AI #MachineLearning #Automation #HealthcareInnovation #Webinar
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Discover the groundbreaking role of strategic partnerships, global talent, and technological advancements in shaping the future of pharmaceutical R&D and commercialization. Learn more in a new blog post from Kirsten Jacobs, PhD, Chief Strategy Officer at PharmaLex: https://lnkd.in/dS-Qs_gc #PharmaLex #PharmaInnovation #BiotechRevolution #Technology
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⏰ Last Chance! ⏰ Registration is closing soon for our CTR Ask The Experts live webinar! Don’t miss your chance to pose your #ClinicalTrialRegulation (CTR) questions to our panel of experts during the live session. 🔔 Secure your spot now: https://lnkd.in/dhHqXHmy Xandra Neuberger Dr. Carolin Gloger Dr. Berit Bachmann, M.D.R.A. #PharmaLex #Webinar #RegulatoryCompliance
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🌞🎧 Dive into the latest insights on pharmaceutical outsourcing with our top QMC #podcast pick this summer! Explore our featured episode: "The New Opportunity in Pharmaceutical Outsourcing: Portfolio Maintenance" with Stephan Hütter Hutter, Senior Manager Regulatory Affairs at PharmaLex. Discover how managing established marketed products can sustain revenue, lower maintenance costs, and ensure compliance. Listen Now: https://lnkd.in/dC-GaP2E #PharmaLex #QMC #PharmaceuticalIndustry #PharmaceuticalOutsourcing #PortfolioMaintenance
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Explore the exciting developments in the pharmaceutical regulatory landscape with Karl-Heinz Loebel as he delves into the history of #eCTD and the future of eCTD 4.0 in the latest article for DIA Global Forum. Discover how eCTD transformed drug submissions and what the roadblocks are for adopting the new eCTD 4.0 standard. Read the full article here: https://lnkd.in/dpcgd5UA Learn more about PharmaLex Regulatory Solutions: https://lnkd.in/ePaZ3HgH Book a Meeting with our Regulatory experts here: https://lnkd.in/e4qDZY5u Sign up for our Monthly Newsletters here: https://lnkd.in/ejiXKmbd #PharmaLex #DIAGlobalForum #eCTD4 #DrugDevelopment
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#WhitePaper 📑 // In an increasingly globalized pharmaceutical landscape, maintaining operational agility is paramount to navigating swiftly evolving regulatory frameworks while upholding top-tier quality and compliance standards. Dive into our latest whitepaper, "𝗥𝗲𝘀𝗵𝗮𝗽𝗶𝗻𝗴 𝗔𝗳𝗳𝗶𝗹𝗶𝗮𝘁𝗲 𝗠𝗼𝗱𝗲𝗹𝘀 𝘁𝗼 𝗦𝘁𝗮𝘆 𝗖𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝘃𝗲 & 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁", offering invaluable insights into the evolving regulatory landscape. Discover strategic solutions to effectively leverage your affiliate models, harmonize regional regulatory standards, and maintain uncompromising compliance while thriving in a fiercely competitive global market. Read more here 🔗 https://rebrand.ly/2ojlphr Stay ahead of the curve and position your organization for success in the dynamic world of pharmaceuticals! #CencoraPharmalex #RegulatoryInsights #AffiliateModels #ComplianceExcellence
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