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Unlock regulatory success with our expert guides on strategy, ICH Q6A, stability data, and more—Elevate your drug development process today...

Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/3AhPizU #pharmamfg #contractmfg

DSI provides a comprehensive suite of analytical services to support your drug development program. Our offerings include Analytical Strategy Development, Analytical Testing/Validation Strategy, IPC & PAT Method Development, Drug Substance and Drug Product Analytical Methods Development Support, and Report Documentation. With our expert consultants, you can ensure your analytical methods are robust and compliant. Learn more about how we can support your analytical needs: https://bit.ly/4hN6MFr #AnalyticalServices #DrugDevelopment #Pharma #Biotech #LifeSciences #MethodDevelopment #PAT #AnalyticalStrategy #DSI #RegulatoryCompliance"

Are you navigating the complex ANDA submission process? Our latest blog offers a comprehensive guide to streamline your generic drug applications. Learn about the critical steps, common challenges, and effective strategies to ensure a smoother path to market. Do not miss this essential resource for Regulatory professionals. https://lnkd.in/gzwSH9e6 #RegulatoryAffairs #GenericDrugs #FDA #ANDASubmission #Pharma

DSI expertly guides clients through the development of intended commercial processes, ensuring alignment with current ICH guidance for a robust regulatory filing. From early development to submission, our team ensures your drug substance is ready for success. Learn more about our drug substance submission services: https://bit.ly/3UPGc4u #DrugSubstance #ICHGuidance #RegulatoryAffairs #DrugDevelopment #Pharma #Biotech #LifeSciences #DSI #SubmissionServices #CommercialProcesses"

Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/3Yuf3Xd #pharmamfg #contractmfg

Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/3Xu5nvN #pharmamfg #contractmfg

🚨New FDA Draft Guidance on URRAs🚨 The FDA recently released a draft guidance on Use-Related Risk Analyses (URRA) for drugs, biological products, and combination products. If you're involved in product development or compliance, this is a must-read! 💡 In our latest blogpost, my colleagues Tiffany and Andrea wrote a comprehensive summary the key components of the guidance. 👉 Swipe through the carousel to get a summary of this summary! For full details, check out the complete article here: https://lnkd.in/eqsvtNAD #HumanFactors #FDA #RiskManagement #Compliance #CombinationProducts #Pharma #ProductSafety

An Investigational New Drug application (aka #IND) is a huge milestone for any company, but even more so for small to mid-size sponsors with limited resources. If you're a #regulatoryaffairs professional trying to figure out how to get it all done, check out our guide to aligning your people, tools, and process for application success! Get the guide 👉 https://lnkd.in/gm3bwMUE #whitepaper #investigationalnewdrug #drugapplication #fdaapplication #fda #drugdevelopment #pharma #lifesciences #clinicaltrials #clinicalresearch #medtech #biotech #clinical #regulatory #regulatoryoperations #agile

Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/4dmRzaS #pharmamfg #contractmfg