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
combination product devices
combination product devices

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

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