Regulatory Centralization​Freyr specializes in helping Life Sciences companies with distributed and de-centralized Regulatory departments to come up with a more centralized Regulatory Operating Model

Key drivers for Centralizing regulatory functions are

  • Better visibility
  • Harmonization of processes and information, resulting in reduced redundancies
  • Ability to ‘fork-lift’ centralized functions to be outsourced or offshored
  • Increased operational, process, and information management efficiency
  • Significant cost reductions
  • Reduce duplication of Regulatory software and other systems that may be used in ‘silos’
  • Better compliance

Freyr can help design a Centralization Program and support in implementing centralization of the following key Regulatory functions

  • Centralized Dossier Preparation / Life Cycle Management
  • Publishing & Submissions 
  • Regulatory Information Management
  • CMC & Change Control
  • Labeling & Artwork functions

Freyr employs a low-cost Global Delivery Model – a combination of Onsite and Offshore activities to provide best cost impact to our clients.