RegDesk Business Case Calculator

Client Information

Company Name

Primary Contact

Title / Role

Date

Cost Assumptions (from questionnaire — Section 7: RA Team & Cost)

Assumption	Unit	Notes
Avg Fully-Loaded RA FTE Cost	USD/year	Salary × 1.3
Productive Hours / Year / FTE	hours	Typically 2,000–2,400
Total RA FTEs (employees)	# FTEs	From questionnaire
RA Contractors / Consultants	# FTEs	From questionnaire
Avg Monthly Revenue per Market	USD/month	Per product, one country

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PLANRegulatory intelligence, standards monitoring, and building global regulatory strategies.

Section 1 — Regulatory Intelligence & Monitoring

PLAN

Time and effort spent tracking regulatory changes, legislative updates, and building global regulatory plans.

Question (from client questionnaire)	Unit	Client Value
1.# People performing regulatory monitoring	# people
2.Hours/week per person on monitoring	hrs/week
3.# NPD regulatory plans per year	plans/yr
4.Avg hours per NPD regulatory plan	hours
5.# Existing-product-to-new-country plans/year	plans/yr
6.Avg hours per existing-product plan	hours

Section 2 — Standards & Legislation Monitoring

PLAN

Effort spent tracking standards, legislation, and guidances — and completing impact assessments when changes occur.

Question (from client questionnaire)	Unit	Client Value
7.# People monitoring standards/legislation	# people
8.Avg hours/week per person on standards monitoring	hrs/week
9.# Standards/legislations changing per year	per year
10.Avg hours per assessment process	hours

TRACKRegistration status, reporting, and stop-ship decision support.

Section 3 — Registration Status & Reporting

TRACK

Effort spent managing registration status and generating reports for internal stakeholders.

Question (from client questionnaire)	Unit	Client Value
11.# Regulatory status queries/reports per month	queries/mo
12.Avg hours per report	hours

BUILDSubmissions, technical documentation, and managing deliverables with regional partners.

Section 4 — Submissions Management

BUILD

Creating country-specific regulatory submissions and coordinating deliverables with regional partners.

Question (from client questionnaire)	Unit	Client Value
13.# Global regulatory submissions per year	subs/yr
14.Avg hours coordinating deliverables per submission	hours
15.Avg monthly revenue per product per market	USD/mo

Section 5 — Submissions & Time-to-Market

BUILD

Effort and revenue impact of regulatory submission timelines.

Question (from client questionnaire)	Unit	Client Value
16.# Global submissions per year	subs/yr
17.Avg days to create one submission	days
18.Avg monthly revenue per product per market	USD/mo

Section 6 — Technical Documentation & Compliance Forms

BUILD

Time spent creating and revising GSPR/EPC checklists and Declarations of Conformity.

Question (from client questionnaire)	Unit	Client Value
19.# GSPR/EPC created or revised per year	per year
20.Avg hours per GSPR/EPC creation/revision	hours
21.# Declarations of Conformity per year	per year
22.Avg hours per DoC creation/revision	hours

MAINTAINChange control workflows and global assessments to keep registrations current.

Section 7 — Change Control & Global Assessments

MAINTAIN

Coordinating and completing change control assessments across global markets.

Question (from client questionnaire)	Unit	Client Value
23.# Change control assessments per year	assess/yr
24.Avg # countries impacted per change	countries
25.Avg hours per country-level assessment	hours

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Savings Summary (auto-calculated — fill inputs on pages 2–3 first)

Pillars	Recoverable Savings	FTE Equiv.
PLANRegulatory intelligence & standards monitoring
Regulatory Intelligence & Monitoring
Standards & Legislation Monitoring
TRACKRegistration status & reporting
Registration Status & Reporting
BUILDSubmissions, documentation & deliverables
Submissions Management
Submissions & Time-to-Market
Technical Documentation & Compliance Forms
MAINTAINChange control & global assessments
Change Control & Global Assessments
Speed-to-Market Revenue (Submissions Management)
TOTAL PROJECTED SAVINGS

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