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

Latest News

27
Jun2018

Over 300 members attend the June New York and London Nets Forum Meetings

Throughout June, Navitas Life Sciences hosted a series of forum meetings in London and...