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 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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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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How have regulatory approval timelines in major markets changed over time? Take a look at our new six-agency briefing to find out. The briefing provides insights into regulatory performance across these six major jurisdictions from 2014-2023 and examines the impact of facilitated regulatory pathways on new active substance approvals. Download the briefing >> https://lnkd.in/ewv_nCsN #RegulatoryScience #pharmaceuticals #RegulatoryAffairs #drugdevelopment #EMA #FDA #PMDA #TGA #Swissmedic #HealthCanada
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📚💊 Proud to have participated in the insightful webinar on "FDA Drug Topics: Important Orange Book Facts"! FDA #FDAWebinar #OrangeBook #Pharmaceuticals #RegulatoryAffairs #DrugDevelopment #HealthcareCompliance #ProfessionalDevelopment
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Explore the key aspects of forced degradation testing, also know as stress testing, in our latest slides! Discover how these studies ensure drug stability and regulatory compliance. Click the link to dive deeper into our comprehensive white paper:https://okt.to/zShf4J #Pharmaceuticals #DrugDevelopment #RegulatoryCompliance #stresstesting #forceddegradation
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Time is running out! Have you registered for Freyr’s free webinar on, “Strategic Guide for License Transfers in South Korea”, scheduled on September 26, 2024? Why late? Register now to gain an in-depth perspective on the Regulatory expectations and challenges to expand your footprint in South Korea. https://lnkd.in/g-CqJ6v3 #SouthKorea #MedicinalProducts #Pharmaceuticals #Manufacturers #MarketEntry #Freyr #FreeWebinar #Webinar #RegulatoryAffairs
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Business Development & Sales Director - China & Associate Partner presso PQE Group (Global Quality & Compliance Solutions for Life Science Industry)
The Importance of Gap Assessment on Data Integrity Before an FDA Inspection 🔎 During the pandemic, the importance of Data Integrity (DI) Gap Assessments waned with the shift to remote work. In 2024, these assessments are crucial for pharmaceutical companies to identify gaps and ensure drug quality. Discover why DI Gap Assessments are essential and how to perform them effectively in Alessio Petrucci's latest blog. Don’t miss out here: https://lnkd.in/dnvaEqwv #DataIntegrity #Pharmaceuticals #QualityAssurance #CSV #CSA #Compliance #PQEGroup
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Last-minute reminder! 𝐉𝐮𝐬𝐭 𝐨𝐧𝐞 (𝟎𝟏) 𝐝𝐚𝐲 left for Freyr’s free webinar on, “𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐆𝐮𝐢𝐝𝐞 𝐟𝐨𝐫 𝐋𝐢𝐜𝐞𝐧𝐬𝐞 𝐓𝐫𝐚𝐧𝐬𝐟𝐞𝐫𝐬 𝐢𝐧 𝐒𝐨𝐮𝐭𝐡 𝐊𝐨𝐫𝐞𝐚.” Register now to gain in-depth insights into Regulatory expectations and challenges. https://lnkd.in/g-CqJ6v3 #SouthKorea #MedicinalProducts #Pharmaceuticals #Manufacturers #MarketEntry #FreyrSolutions #FreeWebinar #Webinar #RegulatoryAffairs
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Time is running out! Have you registered for Freyr’s free webinar on “Overview of PMDA Clinical Trial Consultation”, scheduled for October 15, 2024? Register now to gain an in-depth perspective on the Regulatory expectations and challenges to expand your footprint in Japan. https://lnkd.in/gumnad_G #Japan #MedicinalProducts #Pharmaceuticals #clinicaltrial #Freyr #FreeWebinar #Webinar #RegulatoryAffairs
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Time is running out! Have you registered for Freyr’s free webinar on, “Strategic Guide for License Transfers in South Korea”, scheduled on September 26, 2024? Why late? Register now to gain an in-depth perspective on the Regulatory expectations and challenges to expand your footprint in South Korea. https://lnkd.in/g-CqJ6v3 #SouthKorea #MedicinalProducts #Pharmaceuticals #Manufacturers #MarketEntry #Freyr #FreeWebinar #Webinar #RegulatoryAffairs
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