ROI Math for Regulatory: Prove Value, Get Budget

Regulatory operations often struggle to justify investments because savings and

risk avoidance feel intangible. Without a clear ROI story, budgets flatline.

This playbook gives you the numbers. You will establish baselines, run time

studies, calculate cost-of-delay, and quantify risk reduction so stakeholders see

real value.

Why ROI storytelling matters

Budget approvals: Finance requires defensible numbers to fund automation,

headcount, or system upgrades.

Prioritization: ROI highlights bottlenecks where investment yields the

biggest impact.

Stakeholder alignment: Transparent math builds trust with leadership and

cross-functional partners.

Continuous improvement: Measuring value reinforces a culture of optimization.

Step 1: Establish baseline metrics

Capture cycle times, submission costs, error rates, and rework percentages for

core processes (IND prep, variation filing, change notifications).

Use system data, historical reports, and user surveys to build the “before” view.
Document data sources and assumptions for auditability.

Step 2: Conduct time and effort studies

Observe or survey teams to measure how long key activities take (document prep,

QC review, health authority Q&A response, PV case processing).

Sample multiple teams and regions to capture variability.
Convert hours to cost using fully loaded labor rates.
Highlight high-volume activities where automation could deliver savings.

Step 3: Calculate cost-of-delay and revenue impact

Work with commercial finance to quantify revenue lost per week of delayed

approval or variation.

Include carrying costs for inventory, promotional material reprints, and

opportunity costs.

Build models that show best-case and worst-case scenarios to illustrate range.

Step 4: Quantify risk avoidance

Analyze past CAPAs, inspection findings, or recalls and estimate associated

costs (remediation, fines, product holds).

Use external benchmarks when internal data is scarce; document sources.
Present risk reduction as avoided cost with clear logic linking your initiative

to fewer incidents.

Step 5: Present ROI in a compelling dashboard

Combine hard savings (hours removed, expedited revenue) with soft benefits (risk

reduction, team capacity).

Show payback periods, total benefit versus investment, and sensitivity analysis.
Update quarterly and highlight initiatives accountable for improvements.

45-day roadmap

Days 1-10: Extract baseline metrics from systems and team surveys.

Days 11-20: Run time studies on two high-impact activities and convert to

cost.

Days 21-30: Build cost-of-delay models with finance for upcoming filings.

Days 31-45: Quantify risk avoidance, create the ROI dashboard, and present

to leadership.

Frequently asked questions

What should we show the CFO? Cycle-time reductions, avoided rework costs,

expedited revenue, and risk mitigation quantified in dollars.

How often should ROI be updated? Quarterly reviews keep momentum; refresh

baselines annually as processes improve.

How do we handle soft benefits? Pair them with qualitative evidence and link

to risk mitigation or capacity gains; avoid inflating numbers without proof.

What tools help? Spreadsheet models, BI dashboards, and workflow analytics

from RIMS or QMS systems.

Sustain the win

Review ROI quarterly, update baselines annually, and celebrate teams delivering

measurable improvements. Use success stories to support future investment cases.

When you speak the language of value, budgets follow.