Sowaka Health provides end-to-end Named Patient Programs and Early Access Program management for pharmaceutical partners, from regulatory strategy to last-mile patient delivery.
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India has 1.4 billion people and among the highest burden of oncology and rare disease in the world. The vast majority of novel medicines approved in the US and EU are either not registered with CDSCO or arrive years after global approval. Named Patient Programs and Early Access Programs are the only compliant mechanism to serve these patients today — and they require infrastructure that almost no company in India currently provides at scale.
Fully managed NPP service — per-patient regulatory assessment, sourcing from US and EU licensed wholesalers, import documentation, and last-mile delivery.
Full service details →End-to-end EAP management — regulatory strategy, physician engagement, supply chain setup, safety reporting, and real-world data collection infrastructure.
Full service details →Strategic market access consulting — India entry strategy, CDSCO regulatory roadmap, and competitive landscape intelligence.
Regulatory-grade real-world evidence generation — patient registries, RWD studies, and publications for pre-approval molecules.
Sowaka holds a US Wholesale Drug License and operates a compliant drop-ship export model, giving pharma partners full chain-of-custody documentation on every order.
Every import is processed under Rule 32 of the Drugs and Cosmetics Rules, 1945. We manage the regulatory interface in India so pharma partners do not need a local regulatory team for NPP operations.
Sowaka's medical science liaison network covers Delhi, Mumbai, and Bangalore — creating physician awareness and demand for managed access programs before a molecule reaches formal registration.
For pharma partners granting exclusivity, Sowaka structures real-world data collection alongside NPP and EAP delivery — supporting future CDSCO submissions and global publications.
SowakaOS is our proprietary managed access operating system — the technology infrastructure that sits beneath every NPP and EAP Sowaka runs. It tracks every patient request, order, regulatory filing, and delivery event in a single structured record. The data it generates is the foundation of Sowaka's real-world evidence capability and the engine that allows us to replicate our operating model across new geographies — from India to the Middle East, Southeast Asia, and beyond — without losing compliance or data fidelity at scale.
Platform access and demo — coming Phase 2.We work with a select number of pharmaceutical partners. Conversations are confidential.
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