As 2023 comes to the end, it seems time to highlight the great work PharmaLex experts produced throughout the year providing information and guidance on complex regulatory changes, advancements in #pharmaceutical inspection technology and the importance of data integrity in the industry. 𝗧𝗼𝗽 𝟯 𝗕𝗹𝗼𝗴 𝗣𝗵𝗮𝗿𝗺𝗮𝗹𝗲𝘅 𝗣𝗼𝘀𝘁𝘀 𝟮𝟬𝟮𝟯: 🥇 Understand Implications of Latest Amendment to MDR and IVDR: https://rebrand.ly/4qib0wi 🥈 Data Integrity in Pharmaceuticals: Empowering Trustworthy Decisions from Source to Success: https://rebrand.ly/7qemhb0 🥉Automatic Visual Inspection – What to Consider: https://rebrand.ly/wftcojf While these are our top 3 blog posts of 2023, there's a wealth of knowledge to be found across all our blogs. We encourage you to check them out and stay informed on the latest in the pharmaceutical industry. #PharmaLex #PharmaInsights #ThoughtLeadership #YearInReview
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SAVE THE DATE! Join us on June 28th at 1 PM EST for an eye-opening virtual event that aims to decode the FDA's warning letter process! 📆🔎 Discover the intricacies of this crucial aspect of the pharmaceutical industry and gain insights from industry experts. Don't miss this opportunity to expand your knowledge and stay ahead of the game! 💼💡 Click the link below to secure your spot and mark your calendars. We can't wait to see you there! 👉 https://lnkd.in/eABqGdFf #VirtualEvent #FDAInsights #PharmaIndustry #KnowledgeIsPower #warningletterfromFDA #FDA #warningletter #keynotespeaking #keynotespeaker #businessowners #smallbusiness #pharmaceuticals #consulting
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Vice President of Regulatory and Strategic Development| Member of FDA Advisory Committee for the Pharmaceutical Science and Clinical Pharmacology| Member of OCRA| SDRAN|RAPS| DIA|ASCO
FDA CDRH 2023 Report: Short Summary 1. Breakthrough Device designation to 167 devices 2. 29 out of 167 received marketing authorization 3. Voluntary Safety Device Program (STdP) established with 15 devices enrolled 4. Three draft guidance in 2023 to support medical device innovations 5. Proposed rule to ensure effectiveness of LDTs (Laboratory Developed Tests) 6. Draft International Harmonization Strategic Plan for Alignment of Regulations and Standards #regulatoryaffairs #regulatory #regulatorycompliance #pharma #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #clinregpartners https://lnkd.in/ghx_5hvN
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Our March Case Study is now ready for you to download as a PDF. A 7-minute read worthwhile to understand how we support our customer to navigate the transition of a greenfield site. #pharmaceutical #itot #digitaltransformation #compliance #biopharma #itoperations #managedservices
Our first case study from Q1 2024 is now available as a PDF. Feel free to download and understand: What is involved when moving from a greenfield site to full-scale operations. How to address both IT and OT during the delivery of support. The impact of regulations and FDA guidance on the priorities. Find the associated blog and much more here: https://lnkd.in/eBD6smsG Happy Reading! #pharmaceuticals #biopharma #pharmalab #ITOT #ITOTgap #ITOTconvergence #digitaltransformation #CDS #itoperations
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What are the unintended consequences of the Inflation Reduction Act on clinical development towards subsequent indications? Find out more about the crucial aspects impacting the pharmaceutical landscape and the broader health care industry. A must-read for professionals navigating the complexities of drug development and regulatory policies! Read more here: https://lnkd.in/ewmgGz-r #ClinicalDevelopment #HealthcareInnovation #Pharmaceuticals #RegulatoryPolicies #DrugDevelopment
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Stay informed with the latest from the FDA! The FDA has issued a Technical Conformance Guide to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. This guide is a crucial resource for industry professionals, providing clear instructions on how to access the FDA’s CDER NextGen Portal and submit these reports. Stay ahead of the curve by understanding the data elements to be included in the reports. #fda #fdacompliance #pharmaceuticals #regulatorycompliance #drugmanufacturing #shenclinicalservices Read More: https://lnkd.in/eg7qD3ZY
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Our first case study from Q1 2024 is now available as a PDF. Feel free to download and understand: What is involved when moving from a greenfield site to full-scale operations. How to address both IT and OT during the delivery of support. The impact of regulations and FDA guidance on the priorities. Find the associated blog and much more here: https://lnkd.in/eBD6smsG Happy Reading! #pharmaceuticals #biopharma #pharmalab #ITOT #ITOTgap #ITOTconvergence #digitaltransformation #CDS #itoperations
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Quality by design: such a high-impact concept!
Director at Qualistery | Pharma Events Championing Quality & Operational Excellence in the Industry | Offering exclusive webinar speaking and sponsorship opportunities to GxP suppliers to enhance their brand and reach 🚀
CH Q8 is one of the many critical topics to be covered in our exclusive multi-day event in partnership with Qualio. 🤝 So start your 2024 by participating in this enriching session on ICH Q8 on January 16. 📈 It will be the first session among many, in the 3-day free virtual summit. Various experts across the pharmaceutical industry will share their knowledge on : ✅ Making ICH Q8, Q9 and Q10 best practice natural and automatic ✅ Building a paperless therapeutic quality management system ✅ Aligning with the FDA's Quality Management Maturity program ✅ Understanding 2024 industry expectations and taking them in your stride Register today for this event 👉 https://quali.link/JzjD #pharmaceuticals #pharmaceuticalmanufacturing #regulatorycompliance #regulation #virtualevents
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🚀 Big News! 🚀 We’ve just upgraded our website with everything you need to take your pharmaceutical operations to the next level. 🌟 Want in? It’s simple—visit our Contact Us page, drop your details, and fill out the quick Google Form. ⏳ Act fast, and you could be one of the few to receive a FREE service from our team of experts! This is your chance to experience industry-leading consultation for zero cost, but spots are limited—don’t get left behind!🚀 👉 Contact us today to secure your place before it’s gone! 👈 Visit: www.pharpro.co #PharmaceuticalConsulting #CSV #QualityAssurance #ValidationServices #ThermalMapping #Pharma40 #SafetyStandards #ComplianceExperts #FreeConsultation #PharmaceuticalExcellence #LimitedTime #DontMissOut
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Successful filing of initial IND and IND-LCM submissions. Decode how Freyr succeeded in filing the ad hoc submissions to the FDA and helped the client with their business requirements while maintaining high quality. Download the proven case. https://lnkd.in/gtvyWQPc #Pharmaceuticals #PublishingandSubmissions #INDLCMSubmission #ZeroErrors #FreyrSolutions #ProvenCase
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Explore the Future of Pharma: Real-World Data's Impact! Discover how Real-World Data (RWD) and Real-World Evidence (RWE) are revolutionizing the pharmaceutical landscape. Recent FDA approvals and new guidelines are paving the way. Read our blog for essential steps and tips to make RWD/RWE work for your regulatory submissions. Your journey to efficient, informed innovation begins here: Unlocking the Power of Real-World Data for Regulatory Success | Freyr Digital #RWD #RWE #RegulatorySubmissions #RegulatoryAffairs #Pharmaceutical #PharmaInnovation #FreyrDigital
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Director | International Service Lead (ISL) Europe Medical Device Services
8moExcited to see medical device blog taking the 🥇 place!! With rapidly advancing technologies and new ways to care patients, MDs and IVDs will gain increasing interest also during year 2024 💫✨