ProPharma’s Post

Are you choosing the perfect ELN for your lab? Our blog covers essential considerations, from infrastructure needs to user adoption strategies. Ensure success with expert insights. https://lnkd.in/eK3f6q66 Authors: Warren Antonio Vieira & Claire Hill

Learn more about our Advertising & Promotional Review Consulting: https://lnkd.in/e-WUZfUE. Tap into this week's #ProPharmaPoll. #PharmaInsights

📣 Meet the Expert: Susanna Heinonen, Senior Pharmacovigilance Consultant, QPPV office | EU/UK QPPV, at ProPharma🌟 As EU/UK QPPV, she oversees PV systems, evaluates risk minimization, and collaborates with clients to ensure product safety and compliance. Discover how Susanna and ProPharma’s expert team support global customers with comprehensive pharmacovigilance services. Read more about her: https://lnkd.in/e5CUATzj #MeetTheExpert #WeAreProPharma

From FDA to CE Marking, navigate regulatory hurdles with ProPharma. Discover how a medical device start-up achieved global market entry in record time. Get your copy today: https://lnkd.in/eMaPyBBD

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Navigating the new European Health Technology Assessment Regulation (HTAR) is challenging, but ProPharma is here to help you succeed with your European product launch! Initiated in 2021, HTAR is a game-changer for health technology assessments, unifying clinical perspectives across EU member states for medicinal products, IVDs, and high-risk medical devices. Our latest whitepaper delves into key components like Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), which are crucial for your Market Authorization Application (MAA) to the European Medicines Agency. What’s inside: - HTAR implementation timelines - Best practices for preparing your product launch - Strategies to overcome HTAR compliance challenges Stay ahead of the evolving guidelines and ensure your success in the European market. Complete our form for instant access to our comprehensive whitepaper: https://lnkd.in/e6uKdKUN! 📄 #HTAR #EMA #RegulatoryAffairs

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Discover the power of our global contact center! From multilingual support to 24/7 availability, we ensure seamless service worldwide, tailored to local cultures and regulatory standards. Empower your global outreach today: https://lnkd.in/ehwyeGVA!

Managing vendor audits efficiently while maintaining compliance can be challenging. Explore how outsourcing can streamline processes and maximize cost efficiency in our insightful blog: https://lnkd.in/eBXdTB-A.

Every marketing authorization holder (#MAH) needs a robust pharmacovigilance (#PV) system to ensure product safety. This system monitors the safety of medicinal products and detects any changes in their risk-benefit balance. Key components include the Qualified Person for Pharmacovigilance (#QPPV) and Local Persons responsible for Pharmacovigilance (#LPPV). Learn how to navigate the complexities of PV systems and meet regulatory requirements effectively. Read our blog to learn more: https://lnkd.in/e9K_MJnE.