We help life sciences companies accelerate the process of bringing compliant products to global markets while adhering to country-specific registration 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, constantly 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.
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 in different jurisdictions.
Regulatory Information Management from Product Discovery to Market
- Disparate product and regulatory data along the product value chain
- Ineffective GTIN allocation and management
- Highly manual, time-consuming data gathering and submission process
- Limited resource availability to staff international registration efforts
- Growing, global demand for electronic data exchange driven by evolving regulations
- Revenue losses and fines due to ineffective submissions and delayed compliance renewals
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)
Leading life sciences companies are leveraging regulatory information management systems (RIMS) to consolidate, analyze, and manage global regulatory information, submission planning, activity status, agency correspondence and commitments for the products that they manufacture. RIMS coupled with advanced analytics, machine learning, extended reality, and robotic process automation establishes a powerful digital regulatory thread that delivers 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 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
- Country-specific registration data
- Agency correspondence
- Effective and expiration dates
- Status by part number and sellable location
- Notifications and subscriptions
- Full audit trail and history
- Full reporting capabilities
- Change impact assessment
- REST API and Web services for enterprise system integration
- Country-specific table of contents templates
- Document sharing to a global table of contents (e.g. IMDRF)
- Variation management
- Formatting, rendering and printing
- Submission workflow automation
- Secure distributor and dealer collaboration
- REST API and Web services for enterprise system integration
- UDI and product relationship
- BUDI object model
- UDI metadata and traceability
- US and EU set of attributes
- Workflow capability to review, approve, rework
- Scalable architecture to add country related UDI data
- Integration to gateway submission services
Our Work in Digital RIM
Case Study: Medical Device Manufacturer
Transformed product registration planning and tracking with Accel for RIM, accelerating time to market, reducing cost of submissions and increasing sales in secondary markets
Context
- Disparate and disconnected product, quality and regulatory data across the enterprise
- Ineffective cross-functional collaboration between product development and regulatory affairs for new product registrations
- Highly manual, time-consuming and erroneous product registration planning, tracking, and submission processes
- Limited resource availability to staff international registration efforts
- Delayed new product introductions and product re-certifications resulting in big revenue losses
Approach
- Helped the organization streamline regulatory and product development processes
- Consolidated regulatory systems and established a single global source of truth for product registration and tracking with Accel for RIM
- Integrated RIMS with ERP shipping controls and harmonized it with product change control
- Incorporated the IMDRF table of contents and dynamically linked it to the DHF
- Enabled advanced submission package management with electronic submissions, automated submission workflows and package rendering
- Established an ongoing solution governance framework
Results
- Enabled global visibility to product registrations
- Enabled better regulatory decision-making to support international sales growth
- Reduced risk of regulatory submission errors leading to revenue losses
- Accelerated the SKU reduction process by reducing manual efforts and resource constraints
- Improved impact analysis when implementing product and regulatory changes
