VAULTANA
VAULTANA: Harmonized Regulatory Gateways for India
Accelerating CDSCO Medical Device Clearances for Global Manufacturers. Bridge the gap between EU MDR or US FDA 510(k) dossiers and Indian compliance through automated technical asset mapping and local expert execution.
The Value Stream
How it works
- Step 1
Dossier Ingestion
Drop your finalized EU CE Technical File (STED format) or US FDA 510(k) summary directly into VAULTANA's secure environment.
- Step 2
AI-Assisted Staging
Our system parses, structures, and auto-populates localized Plant Master Files (PMF) and Device Master Files (DMF) mirroring CDSCO standards.
- Step 3
Operon Review Loop
Local compliance specialists at Operon audit your submission package, cross-reference the live predicate engine, and clear document deficiencies.
- Step 4
SUGAM Staging & Hand-off
The fully verified repository is frozen, packaged, and instantly exported to the local consultant for official portal submission.
Manufacturer Benefits
Built for global regulatory teams
Zero Redundant Data Entry
Intelligently map technical documentation across global guidelines without manual re-drafting.
Total Timeline Transparency
Keep international stakeholders aligned using the real-time Indian Medical Devices Rules (MDR 2017) statutory 90-day milestone calculator.
Mitigated Deficiency Risks
Pre-screen and approve files using Operon's dedicated multi-profile reviewer framework before touching official channels.
Unified Regional Portfolio
Track multiple device registrations, clear queries, and monitor active import licenses inside a single secure workspace.
The Strategic Partnership
Founder technology meets on-the-ground regulatory expertise.
Abdul Rahman Shariff — Founder
The technology framework: structured dossiers, review loops, timelines and predicate intelligence.
Operon — Master Regulatory Consultant
CDSCO liaison, SUGAM filings, challans and compliance strategy inside India.