Client Overview
A global medical technology company with a diverse, multi-brand portfolio of medical devices required a more targeted approach to accessing regulatory intelligence. Its Regulatory and Quality teams operated across multiple product categories and markets, making it essential to quickly determine which regulatory requirements applied to specific brands, devices, and product lines.
With a broad portfolio and a large volume of global regulatory information to manage, the organisation needed a scalable way to connect external regulatory requirements directly to its internal product structure.
Background
The client already had access to a comprehensive repository of global regulations. However, locating the requirements relevant to a particular brand or product line remained time-consuming.
Existing search parameters, such as therapeutic area, product category, market, or regulation type, often returned broad sets of information. While the underlying regulations were available, users still had to manually assess which requirements applied to their specific devices.
As the client’s portfolio expanded, the gap between global regulatory information and product-level applicability became increasingly difficult to manage. The organisation therefore required a brand-aware regulatory intelligence framework that could provide a tailored view of applicable regulations across its portfolio.
Services in Scope
Enhancement of the global Regulations Repository with brand and product identifiers
Metadata tagging and mapping of regulations at the brand and product level
Retrospective mapping of existing regulations to the client’s brand catalogue
Configuration of brand-based search and filtering capabilities
Ongoing tagging and maintenance of newly ingested regulatory content
Collaboration across Technology, Regulatory Data Operations, and client teams
Challenge
Key Challenges
Regulatory teams spent significant time reviewing irrelevant or broadly applicable results.
Product-specific compliance assessments required additional manual interpretation.
The absence of brand-level mapping increased the risk of overlooking relevant requirements.
Regulatory and Quality teams lacked a single, tailored view of applicable regulations.
The process was difficult to scale across a growing, multi-brand product portfolio.
Solution
1
Introduced Brand and Product Identifiers
Freyr extended the existing regulatory metadata framework by introducing dedicated brand- and product-level identifiers. This enabled individual regulations to be linked directly to the client’s brands, devices, and product lines.
2
Mapped Existing Regulatory Content
A comprehensive retrospective mapping exercise was conducted to connect existing regulations in the repository with the client’s complete brand catalogue. Relevant product types, categories, markets, and device classifications were used to improve tagging accuracy.
3
Enhanced the Repository Architecture
The Technology and Regulatory Data Operations teams collaborated to configure the repository for brand-based tagging, retrieval, and ongoing maintenance. The enhanced framework supported both historical content and newly published regulations.
4
Built Brand-Based Search and Filtering
A user-friendly search and filter interface was developed, enabling users to retrieve applicable regulations by selecting or searching for a specific brand, product, or device.
5
Established Ongoing Data Governance
New processes were implemented to ensure that all incoming regulatory content was assessed and tagged against the relevant brands at the point of ingestion, maintaining the accuracy and relevance of the repository over time.
Impact
100% Portfolio Coverage
All global product brands were mapped to dedicated brand identifiers within the regulatory repository.
>80% Faster Regulatory Research
Internal teams significantly reduced the time required to identify applicable regulatory requirements.
50% Less Search Noise/h3>
Brand-level filtering reduced irrelevant results and improved the precision of regulatory searches.
1000s of Regulations Tagged
Large volumes of regulatory content were mapped across relevant brands, products, and medical devices.
Faster Compliance Assessments
Teams gained quicker access to product-specific requirements for launches, modifications, and ongoing compliance activities.
Improved Traceability and Audit Readiness
Brand-specific regulatory mapping created a clearer, more defensible connection between regulatory requirements and individual products.
