Yes. based on the threats we identified, i would refine ReguIntel ARIC substantially. the strongest version is not "AI that predicts FDA rejection." it is a narrower, more defensible product. ReguIntel ARIC 1. the core idea ReguIntel ARIC is an evidence-backed regulatory risk intelligence platfor

TAM TOP-DOWN

Start with the AI in regulatory affairs market at $1.31B in 2024. Software is 68.1% of that, giving $892M. The regulatory intelligence segment is 22.0% of the AI regulatory affairs market, yielding $196M. Cross-check against the standalone Regulatory Intelligence Platform market at $1.2B; North America plus Europe is roughly 60% of that, giving $720M. But that figure includes financial services and consumer products. Life sciences is roughly 40% of regulatory intelligence spend per general industry splits, giving $288M.

$1.31B x 68.1% x 22% = $196M; $1.2B x 60% x 40% = $288M; ($196M + $288M) / 2 = $242M, rounded to $260M

TAM BOTTOM-UP

Evidence shows 7,057 pharma companies with active R&D pipelines. Assume 45% are in Phase 2-plus or post-approval stages where regulatory intelligence is operationally critical, giving 3,176 companies. Enterprise-grade regulatory intelligence platforms are priced at $50k-$200k annually; use a midpoint of $120k per year as the blended enterprise and mid-market average (supported by Secureframe at $9k on the low end and known $200k+ enterprise norms). 3,176 companies x $120k per year = $381M globally, rounded to $380M for comparison. This is the source of bottom-up optimism and divergence from top-down.

7,057 x 45% = 3,176 companies; 3,176 x $120,000 = $381M, rounded to $380M

SAM FILTERS

From the conservative TAM of $260M, apply three filters. First, North America plus Europe only (largest and most reachable regulatory intelligence markets at 60% of global, per evidence): $260M x 60% = $156M. Second, companies in Phase 2-plus or pre-NDA actively requiring submission risk analysis, not just passive monitoring: 50% of the geographic slice = $78M. Third, companies not already locked into Thomson Reuters or comparable incumbents under multi-year contracts; estimate 33% are actively evaluable: $78M x 33% = $26M top-down.

$260M x 60% x 50% x 33% = $26M top-down; bottom-up 3,176 x 60% x 50% x $120k = $114M; conservative midpoint $53M

SOM BUILD

Year 1: 6 enterprise clients at $72k average contract value (below market midpoint to win first references) = $430k. Year 2: 16 clients at $72k = $1.15M. Year 3: 44 clients at $72k = $3.17M, rounded to $3.2M. This represents 6% of the $53M conservative SAM, within the plausible range for a new SaaS entrant with a defined wedge (FDA Complete Response Letter pattern analysis) competing against Thomson Reuters and RegAsk over a 36-month horizon. Headwinds evidence confirms long sales cycles and implementation friction.

Year 3: 44 clients x $72,000 = $3,168,000, rounded to $3.2M; $3.2M / $53M SAM = 6% share