From Innovation to Regulatory Readiness.
Your AI-powered regulatory companion for India's medtech journey.
Avishkar Saathi guides early-stage innovators through evidence-based assessment of their innovation, readiness gaps, and likely regulatory pathway.
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Private by design. Privacy & Trust
TRL 1 — Basic principles observed
Scientific research begins; the underlying principles of the idea are observed and reported.
How it works
Identify the product category and verify it through clarifying questions.
Assess technology readiness against the BIRAC TRL framework and highlight evidence gaps.
Indicate the likely CDSCO pathway and the licence forms — MD forms and CT codes — for your product category.
For AI-driven innovations, refer to the relevant ICMR and MoHFW guidance.
Basic: a summary assessment. Pro: the full regulatory roadmap, applicable standards, licensing pathway and an exportable PDF.
Use the Licence Vault to securely store, manage and track your regulatory documents.
Innovation categories supported
Medical Devices
IVDs
SaMD
Software as a Medical Device
New Drugs
Biologics
Vaccines
Advanced Therapeutic Products
Who it is for
Turn your innovation into real-world impact with expert guidance.
Navigate the regulatory landscape for translation and commercialisation.
Plan and progress innovations with structured, evidence-based insights.
Evaluate innovation readiness and regulatory feasibility before committing capital.
Access a structured, evidence-based summary of the innovation and its regulatory position.
Assess the regulatory maturity and TRL stage of innovations seeking funding support.
Support your cohort with structured regulatory readiness guidance at every stage.
Built on trust
Evidence-based assessment
Grounded in official CDSCO, ICMR and MoHFW documentation
DPDP Act 2023-aligned privacy approach
User data fully isolated and secure
Transparent gaps and next steps
Patent application filed with the Indian Patent Office.