FDA Weekly Roundup: New Cancer Drug Approval, Dialysis Fluid Supply Boost, and Record Drop in Youth Tobacco Use This week, the FDA approved Vyloy (zolbetuximab-clzb) for gastric cancer, worked to address IV and peritoneal dialysis fluid shortages post-Hurricane Helene, and reported the lowest youth tobacco use levels in 25 years. Other highlights include updated biosimilar education tools, neonatal drug safety guidelines, and new research on drug impurities. The agency also ended a Salmonella outbreak linked to eggs and launched a pilot to increase transparency in medical device trials. #FDA #CancerTreatment #VyloyApproval #HealthcareInnovation #DialysisFluidSupply #YouthTobaccoUse #Biosimilars #DrugSafety #ClinicalTrials #SalmonellaOutbreak #MedicalDevices #PharmaceuticalNews #NeonatalHealth #SmokingCessation #DrugShortage
About us
🌐 Connecting Global Businesses to Regulatory Excellence! 🌐 Join us at Shudarsana, your trusted partner in navigating the intricate landscape of regulatory compliance. We specialize in providing top-tier regulatory services, ensuring that your business meets and exceeds global standards. 🚀 What Sets Us Apart: Expert Regulatory Services: From compliance assessments to strategic planning, we've got your regulatory needs covered. Global Regulatory Forum: Elevate your industry knowledge and resolve challenges in our exclusive forum, fostering collaboration and innovation. Community Building: We believe in the power of community. Join us in building a network of professionals dedicated to overcoming regulatory hurdles and driving industry success. 🤝 Why Choose Shudarsana? Proven Track Record: Years of experience delivering regulatory solutions across diverse industries. Client-Centric Approach: Your success is our priority. We tailor our services to meet your unique regulatory requirements. Thought Leadership: Stay ahead of the curve with insights from our global regulatory forum, where experts and professionals converge. 🌍 Embrace Regulatory Excellence with Shudarsana! Connect with us today to embark on a journey towards compliance, collaboration, and community-building. Let's shape the future of regulatory success together. #RegulatoryExcellence #GlobalForum #IndustryLeadership
- Website
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shudarsana.com
External link for Shudarsana
- Industry
- Research Services
- Company size
- 2-10 employees
- Type
- Partnership
- Founded
- 2023
Employees at Shudarsana
Updates
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🌟 Stay Ahead with the Latest FDA Regulatory Updates! 🌟 The pharmaceutical industry is evolving faster than ever, and staying compliant is key to staying competitive. 📈✨ The FDA has rolled out new regulatory changes that could impact your business — from drug approvals to manufacturing standards. Wondering how these updates affect you? We've got the breakdown you need to navigate the shifting landscape and ensure your business is always in compliance. 🚀🔍 Don’t miss out on the critical insights that could save you time and resources. Stay informed, stay compliant, stay ahead! 💡💊 #PharmaNews #RegulatoryCompliance #FDAUpdates #PharmaIndustry #StayAhead
FDA Roundup: October 15, 2024
Shudarsana on LinkedIn
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Bringing Clinical Trials to Your Local Healthcare: FDA's New Approach to Faster, More Accessible Drug Development! #ClinicalTrials #FDA #DrugDevelopment #HealthcareInnovation #RealWorldEvidence #MedicalResearch #PatientCare #Pharma #HealthTech #RCTs #Biotech #ClinicalResearch
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🔍 Embracing the Future of Healthcare with AI & Digital Health! 🚀 As AI and Digital Health continue to transform the healthcare landscape, staying informed on key terms and concepts is essential for professionals in the industry. The FDA’s recently released glossary provides valuable insights into crucial terms like AI performance monitoring, assistive AI, and more, helping us stay ahead of the curve. 💡 Check out the key highlights and learn how these technologies are shaping the future of healthcare! #DigitalHealth #AIinHealthcare #HealthcareInnovation #MachineLearning #FDA #AI #MedicalTechnology #HealthTech
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Ensuring Patient Safety with Accurate eRMR Reporting: Trust Shudarsana for Expert Pharmacovigilance Solutions #AdverseEventReporting #PharmaCompliance #MedicalSafety #PharmaceuticalServices #ClinicalSafety #GlobalHealth #DrugMonitoring #SafetyFirst #PharmaConsulting #HealthcareCompliance #PharmaSolutions #RiskAssessment #SignalDetection #RegulatoryAffairs #PharmaExpertise #PharmacovigilanceSolutions
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Where Quality Speaks for Itself—Excellence in Every Detail. #QualityFirst #PharmaceuticalExcellence #ClinicalResearch #RegulatoryAffairs #PharmaQuality #CommitmentToQuality #PharmaServices #ClinicalStudyReport #HealthcareInnovation #TrustInQuality #PharmaSolutions #ShudarsanaPharma #QualityMatters #PharmaExperts #PharmaceuticalServices #TrustedPharma #ClinicalResearchSolutions #PharmaCompliance #LifeSciences #DrugSafety #GlobalRegulatoryAffairs #PharmaIndustry #HealthcareStandards #PharmaceuticalInnovation #CSRExcellence #QualityCommitment #ShudarsanaCompany
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Accelerate your product's journey to market with Shudarsana's strategic regulatory solutions. Local expertise, global reach, and decades of experience—your success is our mission. #RegulatoryStrategy #PharmaSolutions #GlobalCompliance #PharmaConsulting #RegulatoryExperts #LocalExpertise #GlobalReach #PharmaceuticalIndustry #ProductApproval #PharmaSuccess #ClinicalResearch #PharmaInnovation #HealthcareConsulting #RegulatoryAffairs #RegulatoryCompliance #DrugDevelopment #PharmaRegulations #MarketAccess #RegulatorySupport #PharmaConsultants #PharmaServices #ClinicalTrials #LifeSciences #PharmaGrowth #PharmaLeadership #PharmaSolutionsExpert #HealthcareStrategy #RegulatoryPartnership #GlobalPharma
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Power your clinical trials with precision and compliance! Shudarsana’s expertly crafted Investigator Brochures deliver the clarity and regulatory confidence you need for success. Let’s turn your data into a story of innovation! 📑✨ #ClinicalExcellence #InvestigatorBrochure #PharmaInnovation #ClinicalResearch #RegulatoryAffairs #PharmaceuticalServices #DrugDevelopment #GlobalTrials #ClinicalStudy #PharmaSolutions #LifeSciences #MedicalWriting #ResearchAndDevelopment #RegulatoryCompliance
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🔬 Elevate Your Pharma Game with Shudarsana Company! At Shudarsana, we deliver top-quality Clinical Study Reports (CSRs) that meet the highest industry standards. Our meticulous attention to detail ensures accuracy, compliance, and confidence in every report. But that’s just the start—explore our full service portfolio and let us handle the complexities, so you can focus on innovation. Partner with us and navigate the pharma landscape with ease! Email: company@shudarsana.com #PharmaExcellence #ClinicalStudyReports #PharmaceuticalServices #RegulatoryCompliance #QualityFirst #InnovationPartner #PharmaSuccess #LifeSciences #ShudarsanaCompany #DrugDevelopment #PharmaInnovation #ClinicalResearch #HealthcareInnovation
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Shudarsana reposted this
🔍 Explore the Full Spectrum of Pharmaceutical Services with Shudarsana 🔍 At Shudarsana, we pride ourselves on being a trusted partner in the pharmaceutical industry, offering a comprehensive suite of services that cater to the evolving needs of our clients. With over 20 years of experience, we bring unmatched expertise and innovation to every project, ensuring your path to success is smooth and efficient. Our Core Services Include: 🌍 Regulatory Affairs: Navigating complex global regulatory landscapes can be daunting. Our team of experts excels in managing submissions and compliance for both the US and EU markets, ensuring your products meet all regulatory requirements and reach the market without delay. 🛡️ Pharmacovigilance: Patient safety is our top priority. We offer robust pharmacovigilance solutions that monitor and manage the safety of your products throughout their lifecycle, providing you with peace of mind that your innovations are safe and effective. 📊 Aggregate Reporting: Our specialized aggregate reporting services ensure that your data is meticulously analyzed and presented, meeting the stringent requirements of global health authorities. We turn complex data into actionable insights, driving informed decision-making. 🔬 Advanced Scientific Writing: Clear, precise, and impactful communication is key in the pharmaceutical industry. Our team of seasoned writers produces high-quality documentation that supports your products through every phase of their lifecycle, from development to post-market. At Shudarsana, we’re not just a service provider; we’re your partner in progress. Our commitment to excellence, coupled with our deep industry knowledge, ensures that we deliver solutions tailored to your unique needs. Ready to take your pharmaceutical projects to the next level? Let’s work together to bring your vision to life. 🚀 Contact us on: company@shudarsana.com #PharmaceuticalServices #Innovation #RegulatoryAffairs #Pharmacovigilance #Shudarsana #PharmaIndustry #LifeSciences #Biotech #DrugDevelopment #PharmaceuticalInnovation #HealthcareSolutions #ClinicalResearch #RegulatoryCompliance #DrugSafety #PharmaConsulting #ClinicalTrials #GlobalHealth #MedicalWriting