Register For News

Stay in touch with all news and insights from Assion.

Life Cycle Management

Assion provides various services to help our clients during product life cycle:

  • Manage variations and post-approval commitments:
    • Annual Reports
    • Define and implement strategy for managing variations and post-approval commitments
    • Grouping and worksharing variations procedures
    • Regulatory intelligence: watch and assess impact of regulatory changes
  • Develop product value:
    • Assess opportunities in new indications, product repositioning
    • Monitor competition
  • Ensure crisis management
  • Manage unexpected regulatory or safety issues
  • Support to develop Quality Management System

 

Talk to one of our experts

On demand regulatory team an Assion case study

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.