Quants and Trends’ Post

🧬𝗕𝗶𝗴 𝗡𝗲𝘄𝘀 𝗳𝗼𝗿 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗶𝗲𝘀!💊 TGA has updated labeling requirements for paracetamol-containing medicines. These updates include labeling exemptions that allow certain products to be labeled as "Pharmacy Medicine" instead of "Pharmacists Only Medicine." These changes are designed to help pharmacies adapt to new scheduling regulations while maintaining compliance. To understand how these adjustments impact the industry, read more in our latest blog 🔗 https://lnkd.in/dE7-aDZU www.arqon.com & www.attopolis.com May Ng ARQon l Asia Regulatory and Quality Consultancy | Deepak Jamle | ATTOPOLIS@ARQon-Asia Regulatory & Quality Consultancy (MedTech & Drug) #RegulatoryCompliance #ARQonGroup #AttopolisB2B2C #TGAUpdates #Paracetamol #LabellingExemptions #Medicines #PharmaIndustry #HealthcareInnovations #CollaborationInSingapore #MedTech

Is your drug safe and effective? 💉 ▶️Our focus today: Dose Administration, Compatibility & Usability.◀️ 🟣How do you ensure your drug product is designed for safe and effective administration to the patient? 🟣Do you account for variations in drug delivery and use across different settings? 🟣How do you evaluate drug product stability and quality during administration? 🟡Are you confident your administration procedures deliver the correct dose to patients while guaranteeing efficacy and safety at all times? 🟡Do you consider or are requested using a Closed-System-Transfer Device (CSTD), but are unsure about its impact on dose and product quality? When it comes to the development and manufacturing of sterile drug products, there is too much at stake to compromise on quality and safety- and you need to make the right choices. At ten23 health, we support our clients in taking the right decisions. We are specialists in developing sterile drug products that are not only effective but that can also be safely administered. We design tailored strategies from pre-clinical through commercialization, ensuring optimal usability for both patients and healthcare professionals. Our rigorous testing includes simulated administration experiments to guarantee product quality and stability - at all times. Curious to learn more about how we can enhance your drug product delivery and usability? Explore our services here: https://lnkd.in/dzv85Yvy #ten23health #services #drugdelivery #cdmo #pharma #DrugDevelopment #PatientSafety

**PRESS RELEASE**  Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (“Kane Biotech” or “Kane”) announces that it has received ISO 13485:2016 Medical Device Single Audit Program (“MDSAP”) Quality Certification as a designer, developer and manufacturer of medical devices. This achievement speaks to Kane’s demonstrated commitment to bringing quality products to market. These standards require the existence of a comprehensive quality management system with a focus on areas directly impacting patient safety, product performance and reliability. Obtaining the ISO 13485:2016 MDSAP certification allows Kane to apply for regulatory approval of its revyveTM Antimicrobial Wound Gel in Canada, Australia, New Zealand and Brazil. MDSAP is an enhancement of Kane’s previous quality certification which enabled Kane to receive US Food and Drug Administration 510(k) clearance for revyveTM. “This is yet another important milestone for Kane,” said Marc Edwards, President and CEO of Kane Biotech. “There is a need to significantly improve the quality of products that are available to Canadian patients suffering from chronic wounds and today’s announcement brings us one step closer to that end. It also opens the door to Kane expanding its certification and submitting other products for regulatory approval in order to build a comprehensive portfolio of advanced wound care products in these jurisdictions.” The MDSAP program was first introduced in 2016 and allows for an MDSAP-recognized auditing organization to conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. “Through these processes Kane has established a robust quality program associated with the medical device lifecycle to provide assurance consumers will receive safe and reliable products,” said Lori Christofalos, Chief Quality Officer. “I would like to thank the team for all of their hard work as the challenges of preparing a first MDSAP audit are substantial but so are the long-term benefits. One audit allows Kane to meet the quality requirements of multiple regulators.” Read the full press article: https://rb.gy/ex8w5t You can find this video on our website here https://lnkd.in/gUBKucGr #biotech #kanebio #biofilm #chronicwounds #wounds #woundcare #medical #medicaldevice #patent #FDAapprovedProduct #woundgel #revyve #distribution

India is pivotal in global health and safety, contributing 1/6th of the world's safety data. This extensive data helps refine international safety standards, supports R&D, and enhances health outcomes globally. To know more about us visit www.jeevanscientific.com #GlobalHealth #SafetyStandards #ResearchAndDevelopment #IndiaLeadership #HealthInnovation #medicine #medical #pharmaceuticals #pharma #clinical #clinicaltrials #JSTL #Jeevanscientifictechnologylimited #Jeevanscientific #clinicalresearch

The Closed System Transfer Device (CSTD) market is expanding rapidly, driven by innovations and increasing demand for safety in drug handling. Here’s a look at some key players shaping this market: 🔹 BD Medical, Inc – A leader in healthcare solutions, BD Medical, Inc continues to enhance safety with advanced CSTDs that minimize exposure to hazardous drugs. #BDMedical #DrugSafety 🔹 Equashield, LLC – Known for its pioneering technology, Equashield, LLC offers robust and reliable CSTDs that ensure high levels of protection and ease of use. #Equashield #InnovativeCSTD 🔹 ICU Medical, Inc – ICU Medical, Inc combines extensive experience with cutting-edge technology to provide efficient and secure CSTDs for a range of healthcare settings. #ICUMedical #HealthcareSolutions 🔹 Teva Medical Ltd – Teva Medical Ltd brings its expertise in pharmaceutical innovation to the CSTDs market, focusing on solutions that enhance safety and efficiency. #TevaMedical #PharmaInnovation 🔹 Corvida Medical – Corvida Medical is at the forefront of developing CSTDs that offer both safety and ease of integration into existing workflows. #CorvidaMedical #SafeDrugHandling Stay tuned for more updates and detailed analyses! #Healthcare #MedicalDevices #CSTD #Pharmaceuticals #DrugSafety #Innovation #MarketResearch #HealthcareInnovation #MedicalTechnology #DrugHandling #PatientSafety Read Report @ https://lnkd.in/gr6GhDm2

Drug traceability is essential for ensuring patient safety and improving healthcare outcomes. At Tiga Healthcare Technologies we have focused on preventing counterfeit and substandard drugs since the first day and have developed national-scale tracking systems. Our Drug Traceability products set outstanding examples for the healthcare IT industry by end-to-end drug tracking from production to end users. We developed the Pharmaceutical Track and Trace System, branded as DrugXafe, the first in the world and received multiple WSIS e-Health awards. Thanks to unique 2D Data Matrix product codes, DrugXafe tracks and traces drugs across the supply chain, ensuring safety and regulation compliance. For more accessibility, the DrugXafe Mobile App lets patients scan their medicine information, such as expiration dates, recalls, prices and side effects with the data matrix 24/7. As an auxiliary service to DrugXafe, our Aggregation Management System optimizes drug logistics by encoding package and pallet information with QR codes for seamless tracking. Our Drug Traceability products are here to guarantee drug and patient safety and we continue to drive healthcare forward with our proven technologies. Let's shape the future together, as always! #Tiga #HealthcareIT #PharmaIT

On the occasion of World Kidney Day, let us promise ourselves that we will be more careful and concerned about our kidneys as they are very important. . . . INDIA'S ONLY LEGITSCRIPT AND ISO/ IEC 27001 CERTIFIED ONLINE HEALTHCARE PLATFORM Aarogya Aadhar is Approved by BHARAT Government Contact Us: 79-7272-7498/8007-50-7004 . . #arogyaadhar #kidneyday #brain #brainsurgery #treatment #health #braintumours #herbalmedicine #pandemic #healthylifestyle #wellness #healthy #pharmaceutical #pharma #pharmacy #pharmacist #medicine #pharmaceuticals #healthcare #pharmacology #medical #health #pharmacists

#FarmacyFridays💊 Are you a fan or enemy of Big Pharma? Today we kick off International Women’s Day catching up with Moriam Ajala MRPharmS PGCert, founder of The Industrial Pharmacist. We dive deep into the controversial topic of drugs and our communities and if Pharma is really the best sector in the world of Pharmacy. Click the below to hear her honest take on the industry! https://lnkd.in/gvzB-G9n #IWD #BigPharma

CRITICAL DRUG SHORTAGES HIT RECORD HIGH: WHAT'S BEING DONE? As U.S. drug shortages reach a record high, affecting over 300 medicines, it's clear that addressing this crisis requires a multifaceted approach. Recent government actions, including new proposals from Medicare, highlight the urgency for better drug supply chain management and enhanced manufacturing practices. Find out more about the implications for healthcare and the potential legislative changes on the horizon in the article below. Contact QxP to learn how our expert guidance can make a difference: https://lnkd.in/gJUXCkBJ #pharma #biotech #qualityassurance

Pharmaceutical Group of the European Union (PGEU) Recommendations for Tackling Medicine Shortages: Develop Effective Governance: Collaborate closely at both EU and national levels for enhanced #reporting, #monitoring, and communication on #shortages. Empower pharmacists to reduce the impact on European #patients. Improve Communication: Ensure #transparency and early detection by connecting all supply chain actors and national authorities. Increase #access to information across the entire supply chain. Compensate Financial Impact: Recognize and value the resource investment by #pharmacists and #pharmacies in managing shortages. Read the full report at https://lnkd.in/d2_xZyyp