IQVIA MedTech’s Post

Empower your organization with strategies to streamline CDx approval processes. This comprehensive insight brief describes the process for obtaining regulatory approval or clearance for a CDx in the US, and touches on how processes differ in the EU. Download now. https://bit.ly/3YmYMlC #regulatory #CDx

Have a non-novel CDx need and thinking about how FDA CDx reclassification and FDA Final LDT rule might impact your US CDx strategy? Reach out to Boudicca Dx-we are here to support all your US CDx needs in this changing regulatory landscape!

🙉Confused by CPNP and SCNP? Feeling overwhelmed by industry acronyms? 💪Don't let industry abbreviations scare you! Let us guide you through every step of your regulatory journey. 😎 Ready to notify your cosmetic products? Reach out to us for expert assistance. 🥰 Your regulatory expert - PCR awaits! Link: https://lnkd.in/daTQ3gXe #cosmeticsindustry #regulatorycompliance

Struggling with iPSC licensing issues? We've done the hard work for you! We've noticed an increase in customers queries around appropriate licenses and IP when sourcing iPSC lines, cell and methodologies. With iPSC technology gaining increasing prominence in drug discovery, it's now more important than ever to ensure you have the correct licensing and rights to operate. We've made licensing and IP a core priority over the last decade, placing us in a strong position to assist our partners and customers in this area. It's a complex, challenging legal area, but the good news is that we've done the "heavy lifting" so that you don't have to- simply get in touch at [email protected] if you'd like to discuss this with us. Click here to find out more about licensing and IP in the iPSC industry: https://hubs.la/Q02wFn740 #iPSCs #licensing #StemCells #FreedomToOperate #iPSCpatents

As the DSCSA stabilization period approaches its November 27, 2024 deadline, TraceLink is ready to support businesses at every stage of their compliance journey.   TraceLink’s B2N Integrate-Once™ network enables rapid compliance through a network of pre-verified trading partners, providing a streamlined path to meeting regulatory standards without operational disruption.   Learn more about how TraceLink can support your organization in meeting DSCSA requirements: https://bit.ly/47NvJMj   #DrugSupplyChainSecurityAct #DSCSA #Compliance #ProtectPatients 

As the DSCSA stabilization period approaches its November 27, 2024 deadline, TraceLink is ready to support businesses at every stage of their compliance journey.   TraceLink’s B2N Integrate-Once™ network enables rapid compliance through a network of pre-verified trading partners, providing a streamlined path to meeting regulatory standards without operational disruption.   Learn more about how TraceLink can support your organization in meeting DSCSA requirements: https://bit.ly/47NvJMj   #DrugSupplyChainSecurityAct #DSCSA #Compliance #ProtectPatients

As the DSCSA stabilization period approaches its November 27, 2024 deadline, TraceLink is ready to support businesses at every stage of their compliance journey.   TraceLink’s B2N Integrate-Once™ network enables rapid compliance through a network of pre-verified trading partners, providing a streamlined path to meeting regulatory standards without operational disruption.   Learn more about how TraceLink can support your organization in meeting DSCSA requirements: https://bit.ly/47NvJMj   #SupplyChainDigitalization #DSCSA #Compliance 

As the DSCSA stabilization period approaches its November 27, 2024 deadline, TraceLink is ready to support businesses at every stage of their compliance journey.   TraceLink’s B2N Integrate-Once™ network enables rapid compliance through a network of pre-verified trading partners, providing a streamlined path to meeting regulatory standards without operational disruption.   Learn more about how TraceLink can support your organization in meeting DSCSA requirements: https://bit.ly/47NvJMj   #DrugSupplyChainSecurityAct #DSCSA #Compliance #ProtectPatients 

👉 Interacting with regulatory bodies isn't just about reacting and responding, but planning for how to engage those entities as partners. QRx Partners helps its clients develop regulatory strategies that will ensure successful navigation of the most appropriate regulatory pathway for your medical technology products.  🤝 With a focus on early-stage, small, and medium-sized companies, QRx Partners ensures that products get to market as quickly as possible. We know how and when to talk to the regulators. 📧 Contact us any time to start the conversation: DM Christina Pecoraro or email [email protected]. Also, feel free to check out our library of videos on various quality and regulatory topics on YouTube ➡️ https://lnkd.in/gMjAKrTY. #QRxPartners #QRxInforms #QRxSpecialties #MLV #fractional #FractionalCompliance #FDA #FDAcompliance #regulatory #MedTech #FDAregulations #HereForYou

Struggling with iPSC licensing issues? We've done the hard work for you! We've noticed an increase in customers queries around appropriate licenses and IP when sourcing iPSC lines, cell and methodologies. With iPSC technology gaining increasing prominence in drug discovery, it's now more important than ever to ensure you have the correct licensing and rights to operate. We've made licensing and IP a core priority over the last decade, placing us in a strong position to assist our partners and customers in this area. It's a complex, challenging legal area, but the good news is that we've done the "heavy lifting" so that you don't have to- simply get in touch at [email protected] if you'd like to discuss this with us. Click here to find out more about licensing and IP in the iPSC industry: https://hubs.la/Q02wFl670 #iPSCs #licensing #StemCells #FreedomToOperate #iPSCpatents