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Egypt published ( new version 4) Dossier Guidelines. This guideline outlines the necessary documentation needed for registering and re-registering Human Pharmaceutical Products. Applicants must submit comprehensive information for each section to the Egyptian Drug Authority. This information should demonstrate the product's quality, safety and efficacy for the specified conditions as indicated in the proposed labelling #egypt #dossier #regulatory #regulatoryaffairs #ctd #eCTD #ACTD #regulatorypublishing #regulatoryrequirements #regualatorysubmission #pharmaceuticalindustry #dossiercountryspecific #regulatoryinsights

Egypt published ( new version 4) Dossier Guidelines. This guideline outlines the necessary documentation needed for registering and re-registering Human Pharmaceutical Products. Applicants must submit comprehensive information for each section to the Egyptian Drug Authority. This information should demonstrate the product's quality, safety and efficacy for the specified conditions as indicated in the proposed labelling #egypt #dossier #regulatory #regulatoryaffairs #ctd #eCTD #ACTD #regulatorypublishing #regulatoryrequirements #regualatorysubmission #pharmaceuticalindustry #dossiercountryspecific #regulatoryinsights

Are you, like thousands of other pharmaceutical companies, struggling with importing your pharmaceutical products into the US? 🇺🇸📍 Learn the essential steps for importing your FDA related product into the US with success with YSDS Life Science's upcoming webinar 💻 which will cover topics including: 👉🏼 The FDA, their purpose and processes 👉🏼 The important steps of meeting FDA regulations 👉🏼 What to do if your product is put on an “FDA hold” The FDA (Food & Drug Administration) is an agency with rigorous rules & regulations that acts as a protective wall around North America, but rest assured - the expert speakers at this virtual event will unravel the way towards FDA clearance and give you the best tips & tricks for succeeding with your US imports 📦👏🏼 Find out more and register here https://lnkd.in/eqdMB-Md #webinar #support #import #innovation #pharmaceuticals #connectivity #USA

Find overview on 𝐄𝐔 𝐆𝐌𝐏 𝐀𝐧𝐧𝐞𝐱 𝟏 which 𝐬𝐞𝐭𝐬 𝐫𝐢𝐠𝐨𝐫𝐨𝐮𝐬 𝐠𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞𝐬 𝐟𝐨𝐫 𝐬𝐭𝐞𝐫𝐢𝐥𝐞 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐰𝐢𝐭𝐡𝐢𝐧 𝐭𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐔𝐧𝐢𝐨𝐧. It covers key aspects like cleanroom design, personnel hygiene, and environmental monitoring 𝐭𝐨 𝐞𝐧𝐬𝐮𝐫𝐞 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐩𝐚𝐭𝐢𝐞𝐧𝐭 𝐬𝐚𝐟𝐞𝐭𝐲. Compliance with Annex 1 is crucial for pharmaceutical companies operating in the EU to maintain high standards of production and regulatory approval. Adhering to these guidelines fosters trust and confidence in the integrity of pharmaceutical products. 𝐅𝐢𝐧𝐞 𝐫𝐞𝐥𝐞𝐯𝐚𝐧𝐭 𝐮𝐩𝐜𝐨𝐦𝐢𝐧𝐠 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐨𝐧 𝐭𝐡𝐢𝐬 𝐭𝐨𝐩𝐢𝐜 𝐨𝐧 𝐏𝐡𝐚����𝐦𝐮𝐧𝐢 : https://pharmuni.com/ #FDA #PharmaQuality #GMPCompliance #RegulatoryAffairs #PharmaceuticalManufacturing #SterileProducts #EURegulations #QualityControl #DrugSafety #PharmaTraining #LinkedInLearning

cGMP regulations are a vital part of the pharmaceutical industry, ensuring the quality and safety of drugs, medical devices, food, and other products. By following these regulations, manufacturers can: 👉 Minimize the risk of contamination 👉 Maintain consistent product quality 👉 Meet regulatory requirements Are you familiar with cGMP regulations? Share your thoughts in the comments below! #CGMP #pharmaceutical #manufacturing #qualitycontrol #renejixpharma

🚀 Alert! The ICH Q3C(R9) "Guideline for Residual Solvents" has successfully navigated its journey to Step 4 of the ICH Process as of January 24, 2024. 📅✨ ✅ What's new? Updated standards 📊 Enhanced safety protocols 🛡️ Streamlined procedures ⏩ Impact of solvent volatility on the test method should be considered in the validation. This revision promises to set a new benchmark in our quest for excellence in pharmaceutical safety and quality. 🌟 . #ICHQ3CR9 #PharmaInnovation #SafetyFirst 🔵 #Pharmaceuticals 🔵 #QualityAssurance 🔵 #RegulatoryAffairs 🔵 #ICHGuidelines 🔵 #ResidualSolvents 🔵 #PharmaSafety 🔵 #PharmaStandards 🔵 #Innovation 🔵 #HealthcareExcellence 🔵 #DrugSafety 🔵 #PharmaIndustry 🔵 #ProfessionalDevelopment 🔵 #ContinuousImprovement 🔵 #SafetyProtocols 🔵 #GlobalHealth 🔵 #PublicHealthSafety

#𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐑𝐞𝐦𝐢𝐧𝐝𝐞𝐫! 🚀 Discover the Future of Regulatory Affairs in the Pharmaceutical Industry with 𝐃𝐨𝐬𝐬𝐩𝐥𝐨𝐫𝐞𝐫™! If you are looking to increase efficiencies in preparing eCTD and other regulatory dossiers, you won't want to miss our 𝐅𝐑𝐄𝐄 webinar on 7th November at 10:00 AM ET. 𝐎𝐧𝐥𝐲 1 𝐰𝐞𝐞𝐤 𝐭𝐨 𝐠𝐨! 𝐀𝐥𝐥 𝐫𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐧𝐭𝐬 𝐰𝐢𝐥𝐥 𝐫𝐞𝐜𝐞𝐢𝐯𝐞 𝐭𝐡𝐞 𝐫𝐞𝐜𝐨𝐫𝐝𝐞𝐝 𝐬𝐞𝐬𝐬𝐢𝐨𝐧 - 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐧𝐨𝐰: https://lnkd.in/gkhAQweU 💡 This client case study webinar will explore how our advanced cloud-based dossier management solution, 𝐃𝐨𝐬𝐬𝐩𝐥𝐨𝐫𝐞𝐫™ eliminates manual steps in the exchange of regulatory dossiers and allows you to share, view and review eCTD, NeeS, and other dossier formats from any region and access them in any location! Find out more about this topic in our blog: https://lnkd.in/gHHTJrPc #compliance #regulatorycompliance #regulatoryaffairs #webinar #webcast #regulatorysubmissions #ectd #ectdsubmissions #nees #dossier #regulatorydossier #pharma #pharmaceuticals #pharmainnovation #regulatoryexcellence  

Today, Bloom Public Health, represented by Oluwasegun Idowu, a GMP/GDP specialist at Bloom Public Health, was one of the facilitators in a one day virtual regulatory requirements workshop to increase knowledge and understanding of international regulatory frameworks for COVID-19-relevant medical and pharmaceutical product manufacturing (CMPP) companies in the #SADC region on behalf of #GIZ. The training topic covered the validation and qualification of a clean room for manufacturing sterile and non-sterile products based on #ISO14644 basic requirements and validation. Bloom Public Health is committed to strengthening the capacities of medical and pharmaceutical product manufacturers in #Africa to be on par with internationally accepted standards. #technicalsupport #capacitybuilding #virtualworkshop #validation #qualification #ISO14644 #BloomPublicHealth #GIZ #FCD #KabodMedic #SADC #Africa

What is ALCOA+ ??? ALCOA+ is a set of principles that ensures data integrity in the life sciences sector. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas, particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain. As well as being crucial for compliance reasons, ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices). Their relevance is also growing as manufacturers in the life sciences sector continue to implement Industry solutions and processes.

cGMP + GMP vs. non-GMP sample storage- does it really matter? YES! Current Good Manufacturing Practices (cGMP) and GMP are guidelines written by the U.S. FDA to ensure drugs, pharmaceuticals and more meet minimum safety and quality standards for use as intended. All SciSafe facilities are fully cGMP compliant and accredited to industry standards for pharmaceutical, component and biologic storage. By choosing SciSafe to store any non-GMP samples, you are gaining the additional benefit of these strict handling standards at no extra cost to your organization. Stay tuned for an upcoming white paper comparing GMP and other industry standards. #outsourcedstorage #GMP #cGMP #samplestorage #researchstorage