Combination Products and Devices
Will you be Ready to Comply with the Combination Product Regulations?
Key Issues that Organizations are Facing
- Different regulatory definitions for devices and combination products
- New and changing regulations: Increasing enforcement with new regulations in EU, China, India etc.
- Complex new technologies blurring the line like novel drug-delivery systems, combination packs, personalized medicine and apps
- Divergent device regulatory requirements in complaint handling and incident reporting across different regions
- Regulatory scrutiny
- Cross-functional processes inadequately implemented
- Lack of end-to-end oversight and control
Navitas Life Sciences Provides an Integrated Approach Leading to Impactful Results
- Align drug and device processes while accounting for product differences
- Work cross-functionally across the organization (Quality, Regulatory and Safety)
- Build up internal device expertise
- Leverage upcoming EU Medical Device Regulations as a catalyst for change
Deliverables
- Define and implement governance structure that aligns processes and the organization and ensures compliance
- Updated processes and procedures to allow for transfer of quality and safety information with clear triggers while maintaining oversight
- Regulatory reporting matrix defined and agreed across sponsors and vendors
- Technology review and roadmap for implementing additional device reporting
Benefits
- Alignment on device and combination product definitions across regions
- Compliance with regulatory requirements for various countries and regions
- Efficient process breaking the siloed mentality and providing cross-functional oversight from quality, regulatory and safety
- Technical solution to implement the new regulatory requirements