Regulatory Data Foundation
Establish a governed master data repository for products, markets, registrations, DMF/CEP/LOA records, and authority relationships — the foundation for planning, submissions, and lifecycle tracking across regions.
Replace fragmented regulatory records with one governed data foundation
Regulatory teams often track product registrations, market authorizations, and supporting letters across spreadsheets, shared drives, and disconnected systems. When master data is inconsistent, every downstream submission and renewal inherits that risk.
Regulatory Data Foundation in AmpleLogic Regulatory Information Management System centralizes global market setup and master data for pharmaceutical product regulatory life cycle tracking, including DMF tracker, CEP, and LOA context across authorities.
Clean master data gives submission planning, preparation, execution, and post-approval tracking a shared source of truth — without claiming that data alone replaces regulatory judgment.
Explore AmpleLogic Regulatory Information Management SystemWhat Regulatory Data Foundation enables
Practical capabilities regulatory affairs teams use across planning, submissions, lifecycle tracking, and monitoring.
Global Market Setup
Configure markets, authorities, and regional requirements that shape how products are tracked worldwide.
Product Registration Master Data
Maintain product and registration records that feed planning, submissions, and lifecycle tracking.
DMF, CEP & LOA Context
Organize DMF tracker, CEP, and LOA information alongside product and market records.
Authority Relationships
Link products and filings to the health authorities that govern each market.
Centralized Repository
Keep regulatory master data in one controlled place instead of scattered files and emails.
Data Governance Support
Support attributable updates and controlled access to regulatory master records.
How this capability fits the regulatory submission lifecycle
From regulatory data foundation and planning through preparation, execution, review, lifecycle, monitoring, and analytics.
Step 01
Market & authority setup
Define markets and health authority context for the products you manage.
Step 02
Product master data
Capture product, dosage form, and registration attributes needed for RIM workflows.
Step 03
Supporting records
Associate DMF, CEP, LOA, and related regulatory documents with the product context.
Step 04
Market authorization links
Connect products to market authorizations and regional filing status.
Step 05
Controlled updates
Maintain master data changes with role-based access and traceable updates.
Step 06
Downstream readiness
Feed planning, preparation, execution, and lifecycle modules from the same foundation.
Outcomes regulatory affairs teams can expect
Benefits focused on this Regulatory Information Management System capability.
Reduce data blind spots
Give regulatory teams one place to find product, market, and authority context.
Improve submission readiness
Start planning and dossier work from consistent master data instead of reconciling files first.
Support global scale
Extend the same data model across additional markets as the portfolio grows.
Strengthen auditability
Keep master data changes attributable within the RIM platform.
Built to support regulated pharmaceutical operations
Controls and practices most relevant to this RIMS capability.
Controlled master records
Support governed storage of regulatory product and market data used across filings.
Role-based access
Limit master data create and update activities to authorized regulatory roles.
Traceable updates
Maintain visibility into how regulatory master data changed over time.
How the data foundation connects across the RIMS lifecycle
Master data underpins submission planning, dossier preparation, execution tracking, review management, and post-approval lifecycle work.
Into submission planning
Use product and market context to define requirements, timelines, and milestones.
Into preparation & execution
Assemble and track submissions against consistent product and authority records.
Into lifecycle & monitoring
Track renewals, variations, and commitments from the same registration foundation.
Our Global Offices
We are where you need us to be. Connecting globally, delivering locally.
India
Melange Tower, 2nd Floor, Wing-C, Patrika Nagar, HITEC City, Madhapur, Hyderabad - 500081, Telangana, India
United States (Dallas)
17330 Preston Road Suite 200D, Dallas, TX, 75252
Canada (North York, Toronto)
5255 Yonge Street Suite 201, North York, ON, M2N 6P4
Australia (Melbourne)
Level 14, 330 Collins Street, Melbourne, VIC, 3000
South Korea (Daegu)
Daegu Trade Centre, 8/F. 489, Dongdaegu-ro, Daegu, 41256
Ireland (Dublin)
Block 1, Blanchardstown Corporate Park Ballycoolen Road, Dublin, D15 AKK1
Singapore
1 Scotts Road, #24-10 Shaw Centre, Singapore, Singapore, 228208
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