Provenance and AI speed, evidenced together. Indian pharma faces unique IP and patient-safety exposure across discovery, trials and pharmacovigilance. SMMARUN turns that exposure into a single operating discipline.
Model risk and reproducibility for AI in target validation, lead optimisation, and assay-design support. The reasoning trace is part of the lab notebook, not a sidecar.
Bias, consent, audit. Trial-data hygiene with row-level lineage. Every classification reversible on an auditor's clock.
Adverse-event signal detection, AI-driven causality assessment, ICSR triage with reversible classification. Built so a regulator can reconstruct the AI's contribution to any decision, in writing, at any later date.
AI-enabled tools for regulatory drafting, CMC submissions, and software-as-a-medical-device. Export-ready governance from prototype, classification mapping aligned to the strictest market.
AI-assisted drug discovery generates IP that crosses borders. Provenance controls held against ICMR, FDA, CE, CDSCO, PvPI and DPDPA. Pharmacovigilance and clinical trial integrity, evidenced under audit.
Read more →Your AI investments in research, manufacturing, and pharmacovigilance deliver returns because the controls hold while the system moves. The estate is held against ICMR, FDA / CE, CDSCO, PvPI and DPDPA as one operating posture.
Research leaders need vocabulary the regulator recognises. Governance committees capable of holding the line when AI-generated evidence enters a submission. Calibrated for principal investigators, programme leads and board sponsors in turn.
Read more →Calibrated for principal investigators, research leadership, regulatory affairs, and board sponsors in turn. Curriculum anchored to ISO 42001, NIST AI RMF, ICH GCP, and the India regulatory stack. Co-branded certification with premier academic institutions.
ByteVerity's Kernel and Vault planes deliver mandatory-coverage proofs for clinical data. Compilable stubs prevent IP leakage to offshore teams. EvoluteIQ automates supply chain and pharmacovigilance with full audit trace.
Read more →EvoluteIQ's enterprise automation scales pharmacovigilance and supply chain workflows with guardrails encoded as policy. ByteVerity's Kernel and Vault planes prevent IP leakage on AI-assisted drug discovery and deliver mandatory-coverage proofs for clinical data. Full audit trace on every orchestration step.
Audit your AI estate against ICMR, FDA / CE, DPDPA, and CDSCO. Surface the three highest-consequence agents and the three governance gates that must hold first. The output is a register of named risks, prioritised by consequence.
EvoluteIQ stood up with pharma-specific guardrails (provenance, reproducibility, consent, bias) encoded as policy. Two pilot agents move from intake to production with full audit trace, on a path the regulator could follow.
Governance committee operationalised, model owners named, R&D and pharmacovigilance roles re-cut for an AI-enabled operating model. The SMMARUN masterclass curriculum delivered. You leave operating the practice, not waiting on the platform.
