CG Executive Summary — Regeneron Validation Transformation

Structural Efficiency

> 85% efficiency gain through AI-enabled CSA, accelerators & centralized governance.

AI-Enabled Delivery

AI-assisted documentation, test generation & intelligent review embedded into Validation workflows.

Seamless Transition

Fully absorbed by CG – no separate cost, no disruption to ongoing work.

Core + Flex Model

Baseline team sized for steady state; flex layer activates for peaks and built-in buffer.

Lowest Total Cost of Ownership

Fewer FTEs, faster cycles, reduced rework – CG optimizes total cost, not just hourly rates.

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Structural Efficiency

CSA-first methodology — risk-based validation per FDA 2022 CSA guidance, effort proportional to patient safety risk
AI accelerators — auto-built traceability, AI pre-screened reviews, ICH Q9 risk pre-population
Centralized governance — single framework, shared templates, Polarion ALM across all systems
Reuse library — 200+ prior engagements, every new system starts 40-60% complete

~1,200 hrs (CSV) → ~180 hrs (CSA + AI) per system

AI-Enabled Delivery

Requirements traceability — AI parses URS/FS/DS, auto-maps IDs, flags gaps; humans approve
Test script generation — AI drafts OQ/PQ steps; humans review and execute
Document review — AI pre-screens completeness & SOP currency; humans validate findings
Deviation & risk — AI builds timelines, scores ICH Q9 risk; humans approve disposition

Iris — Audit & Review Ada — CAPA Nova — Deviations Sage — Complaints Aria — Migration

Seamless Transition — 12 Weeks, Zero Cost

Wk 1-3

Shadow

Knowledge capture

Wk 4-6

Parallel

Joint governance

Wk 7-9

Handover

Full ownership

Wk 10-12

Stabilize

Baseline metrics

Core + Flex Model

CORE 8-10

Dedicated leads, QA reviewers, CSA specialists. Fixed monthly.

FLEX 4-6

Surge for peaks. Pre-vetted. T&M, 5-day activation.

AI ×5

Iris, Ada, Nova, Sage, Aria. Always-on. Included in core.

Core handles 80% of workload at predictable cost
Each FTE ~40% more productive with AI — 8-10 people deliver 12-14 FTE output

Lowest Total Cost of Ownership

Cost Driver	Current	CG Model	Savings
Validation FTEs	14 FTEs	8-10 Core + Flex	25-30%
Cycle Time	16 wk avg.	10 wk (CSA+AI)	37% faster
Rework	~15% effort	~5%	67% less
Review Cycles	3-4 rounds	1-2 rounds	50% fewer
Transition	Separate SOW	Absorbed, 12 wk	$0
Tools / Platform	Separate licenses	CLAIRE included	$0

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