Requirements Repository is a core module within the Corlytics Regulatory Intelligence platform, designed to support Health and Life Science organisations in managing and analysing global regulatory requirements. It provides a structured digital library of content and strategic submission requirements, enabling teams to compare, analyse, and maintain submission data across jurisdictions, product types, and markets.
With powerful filtering, versioning, and cross-comparison tools, the module helps streamline regulatory planning and ensures that submissions are built on the most current and relevant standards. The repository serves as a single source of truth for submission documentation and regulatory expectations, improving accuracy, alignment, and speed to market.
Benefits
Faster Submission
Preparation
Easily identify applicable
requirements for each
submission type and
jurisdiction, saving
time and effort in pre-
submission planning, while reducing the risk of non-
compliance.
Efficiency & Reduced
Ensure alignment of regulatory strategies
and documentation by referencing a single source of truth across geographies.
Institutional Knowledge Retention
Capture and retain historical changes, rationales, and best practices to ensure consistent and high-quality submissions.
Regulatory Change Traceability
Maintain a full audit trail of how changes in regulatory guidance impacted requirements and actions taken in response.
This supports strategic decision-making
Key features:
- Centralised digital library of global regulatory requirements across markets and submission types.
- Cross-jurisdictional comparison tools to analyse differences and similarities between local and global requirements.
- Version control and audit trail to track updates and maintain a defensible compliance position.
- Custom tagging and strategy views to support submission planning based on product type, market, or regulatory theme.
- Seamless integration with Guidance Assessment, allowing users to update requirements based on evolving guidance.
- Linkage to internal SOPs and templates, enabling streamlined content planning and reuse.
Regulatory Platform for Health and Life Sciences
Insights for Health and Life Sciences
Read our use cases and case studies for our Health and Life Sciences clients and how we are helping organisations stay ahead of the regulatory curve while fostering a culture of accountability and transparency. Stay informed, stay compliant, and discover the future of RegTech with us
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