We empower life sciences companies to rapidly launch compliant products worldwide by navigating complex country-specific requirements
To compete and grow in a global market, life sciences companies must be able to scale international sales – quickly. This means developing products that comply with global regulations, adhere to country-specific submission processes and meet diverse customer needs.
However, today’s complex, ever-changing regulatory environment creates a significant amount of risk that must be managed with a globally unified product registration, submission and ongoing market tracking process.
Non-compliance is not an option – it is costly, can be damaging to a brand and harmful to patients.
Kalypso is a Gartner Representative Vendor for Life Science Regulatory Information Management Solutions
The Imperative to Transform Regulatory Information Management
In addition to the evolving global regulatory landscape, manual business processes, complex enterprise ecosystems and resource constraints make it challenging for companies to efficiently track regulatory changes, collect, categorize and transmit product information to regulatory bodies around the globe.
Regulatory Information Management from Product Discovery to Market
- Disparate product and regulatory data along the product value chain
- Increased time-to-market and missed approval targets, particularly in secondary markets
- Revenue losses and fines due to ineffective submissions and delayed renewals
- Highly manual, time-consuming data gathering and submission process
- Limited resource availability to staff international registration efforts
- Increased overhead preparing for the implementation of new regulatory requirements such as EUMDR
- Recalls or market lock-out due to product changes invalidating a registration or license
- Compliance failures, such as shipping to an unauthorized country or failing to notify a country of a recall
- Global regulatory impact assessments are resource intensive and challenging to coordinate across regions
Design divisions don't have enough staff to support international registration efforts
VP of Quality and Regulatory, multinational medical technologies corporation
We lost millions of dollars in international market sales because of ineffective product registration and renewal processes
Global VP of Regulatory Assurance, multinational medical technologies corporation
To minimize the risk and burden of regulatory compliance management companies are looking for new ways to overcome this growing challenge.
You might be asking...
How do we efficiently collect, organize, and transmit data to regulatory agencies in their specified formats?
How do we reduce the effort and cost of our regulatory planning, submissions and tracking?
How do we quickly respond to evolving regulatory requirements around the globe?
How do we learn from previous regulatory registrations to improve future submissions?
Digital Regulatory Information Management (RIM)
Unlock efficiency in global regulatory information management with RIMS. Life sciences leaders consolidate data, plan submissions, monitor status and manage communications using RIMS. The regulatory digital thread powered by analytics, machine learning, extended reality and robotic process automation, ensure connectivity, traceability, automation and predictive insights.
Digital RIM Capabilities
- Plan which products to register in which countries, by when, by whom, etc.
- Execute and submit submission packages efficiently using country-specific templates, formatting, rendering, and advanced collaboration and content management features
- Track agency correspondence, registration status by part number and location, expiration dates, certificates, licenses and more
- Integrate with master product data and provide downstream systems with information to control salability and shipping
- Improve searching, reporting and auditing features to analyze cycle times, spot trends and identify problems
Business Value Benefits
- Expand and accelerate international sales: reduce time and effort to register product variations per jurisdictional requirements; know where product variations are registered and salable
- Reduce regulatory risk: prevent shipment of unauthorized or non-compliant products; understand the impact of design changes; respond quickly to changing regulations; know where to report adverse events or conduct product recalls
- Make better decisions: improve planning and strategic decisions with better information
- Reduce manual effort of strained resources: free people to focus on higher value work
How We Help Clients Improve Digital RIM Capabilities
Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions.
Accel for Regulatory Information Management (RIM)
- Designed to quickly deploy foundational RIM capabilities
- Based on industry-leading RIM practices and implementations
- Pre-configured for rapid implementation with a validated software system
- Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages
Accel for RIM Modules
Companies can choose to implement the entire RIM solution or one of the three modules:
- Plan and track registrations globally
- Maintain SKU-Registration traceability
- Proactive expiration and renewal date notifications
- Enforce shipping controls via integration
- Status by part number and sellable location
- Full audit trail and history
- Extensible regulatory change impact assessment
- Manage global and country-specific templates for regulatory files
- Create and maintain GSPR Checklists
- Automate document sharing to a global table of contents (e.g. IMDRF)
- Publish and archive submission packages
- Manage Health Authority Correspondences
- Track market authorization activities with end-to-end submission workflows
- Secure distributor and dealer collaboration
- Dynamic dashboards and analytics with Microsoft Fabric and Power BI
- Interactive world view for market performance
- Integrated compliance data reports per market
- Tailored KPIs and reporting metrics
- Ability to Integrate with data from other enterprise systems
Implementation Services for Additional RIMS Capabilities
- Scalable UDI model integrated with product and change data
- e-Submissions via 3rd Party Gateway
- Supports multiple UDI databases (GUDID, EUDAMED, etc.)
- Future-proof (Extensible framework)
- UDI metadata and traceability
- Workflow capabilities to review, approve and rework UDI data sets
- Manage Country-Specific requirements for target markets
- Notifications of changes in Standards and Country Regulations
- Gap assessments for changes to regulations and standards
- Integrations to Standards Service Providers for near real-time updates
- Bespoke data feeds for regulatory intel and post-market data
- Tailored workflows to track Regulatory Requests for NPI, NTM, Product Changes, etc.
- Bridge the gap between planning and execution for market access across complex regulatory teams
- Record and track major milestones and dates (planned vs. actual)
- Establish comprehensive regulatory plans for the entire product lifecycle
Our Work in Digital RIM
Case Study: Medical Device Manufacturer
We helped a global medical device manufacturer accelerate product registrations and reduce submission costs across international markets.
Our client needed to improve the speed, accuracy and scalability of its registration planning and tracking process, which was highly manual and disconnected across regions.
Product, quality and regulatory data were siloed, collaboration between product development and regulatory affairs was inconsistent, and limited resources made it difficult to keep up with re-certifications and new market launches, resulting in costly delays and lost revenue.
We implemented Accel for RIM as a centralized source of truth for global product registration. The solution integrated with ERP shipping controls and product change processes, incorporated the IMDRF table of contents linked to the DHF and enabled automated submission workflows with electronic package rendering and tracking.
Regulatory teams now have a harmonized system to manage registrations efficiently with better visibility, fewer errors and improved impact analysis for product changes.
Our work reduced manual effort, improved global regulatory coordination and accelerated product availability in secondary markets, leading to faster time to market, smarter decision-making and increased sales.
Thought Leaders
