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Beyond the Database: Why RegDesk Alternatives Are Key for MedTech and How Pure Global's Integrated Strategy Redefines Global Market Access
Many MedTech and IVD companies rely on regulatory intelligence platforms like RegDesk for global expansion, only to discover that data alone doesn't get a product to market. This episode of MedTech Global Insights explores the critical gap between knowing the regulations and successfully executing a market submission. We break down the limitations of a platform-only approach and reveal what a truly effective alternative looks like.
We move beyond simple databases to discuss an integrated strategy that combines advanced AI and data tools with the indispensable value of local, on-the-ground expertise. This model transforms a complex, multi-vendor process into a streamlined, single-partner solution, closing the execution gap and accelerating your path to revenue in over 30 global markets.
Consider this real-world scenario. A promising MedTech scaleup planned a simultaneous launch in Mexico, Australia, and the UAE. A data platform gave them the document checklists, but left them to find a local sponsor in Mexico, navigate the TGA's unique conformity assessment in Australia, and manage the complex Arabic translation and portal requirements for the UAE. They were drowning in administrative work and unforeseen costs before a single application was submitted, jeopardizing their entire expansion plan.
Key Takeaways:
- Why is a regulatory database alone often insufficient for successful global market entry?
- What are the hidden costs and risks of building a fragmented network of local consultants?
- How does an integrated service model solve the crucial “last mile” problem of regulatory submissions?
- What does a “single process, multiple markets” approach actually look like in practice for a MedTech company?
- Why is local, in-country representation more than just a name on a registration form?
- How can AI be used to accelerate the creation of technical dossiers, not just for research?
- What are the key strategic differences between a data provider and a true global market access partner?
To learn more, contact us at [email protected] or visit https://pureglobal.com/
View all episodes
By Ran ChenMany MedTech and IVD companies rely on regulatory intelligence platforms like RegDesk for global expansion, only to discover that data alone doesn't get a product to market. This episode of MedTech Global Insights explores the critical gap between knowing the regulations and successfully executing a market submission. We break down the limitations of a platform-only approach and reveal what a truly effective alternative looks like.
We move beyond simple databases to discuss an integrated strategy that combines advanced AI and data tools with the indispensable value of local, on-the-ground expertise. This model transforms a complex, multi-vendor process into a streamlined, single-partner solution, closing the execution gap and accelerating your path to revenue in over 30 global markets.
Consider this real-world scenario. A promising MedTech scaleup planned a simultaneous launch in Mexico, Australia, and the UAE. A data platform gave them the document checklists, but left them to find a local sponsor in Mexico, navigate the TGA's unique conformity assessment in Australia, and manage the complex Arabic translation and portal requirements for the UAE. They were drowning in administrative work and unforeseen costs before a single application was submitted, jeopardizing their entire expansion plan.
Key Takeaways:
- Why is a regulatory database alone often insufficient for successful global market entry?
- What are the hidden costs and risks of building a fragmented network of local consultants?
- How does an integrated service model solve the crucial “last mile” problem of regulatory submissions?
- What does a “single process, multiple markets” approach actually look like in practice for a MedTech company?
- Why is local, in-country representation more than just a name on a registration form?
- How can AI be used to accelerate the creation of technical dossiers, not just for research?
- What are the key strategic differences between a data provider and a true global market access partner?
To learn more, contact us at [email protected] or visit https://pureglobal.com/