Regulatory Affairs

or call +44 1624 672777

Our Regulatory Affairs services include:

Pre-authorisation

 

  • Dossier review / Gap analysis
  • Development of regulatory strategy
  • Liaison with Regulatory Authorities
  • Creation of Product information:
    • SmPC, PIL and labelling
    • Mock-ups
    • Braille verification
    • Readability user testing
  • Risk Management Plans
  • Quality Overall Summaries
  • Clinical and Non-clinical Overviews
  • MA application submissions:
    • National Procedures
    • Decentralised (DCP) and Mutual Recognition (MRP) Procedures
    • Centralised Procedures
  • Preparation and submission of responses to Authorities

Post-authorisation

 

  • Variation preparation and submissions
  • Maintenance of Product Information, including preparation and submission of updates (safety variations)
  • MA renewals, transfers and withdrawals
  • Line extensions
  • Sunset clause submissions
  • PSUR writing and submissions
  • Maintenance of Risk Management Plans
  • XEVMPD maintenance

Other Regulatory Affairs services that we offer:

eCTD publishing

 

  • MA applications
  • Variations
  • Conversion from NeeS format
  • Baseline submissions

Ad hoc support

 

If you occasionally need an additional resource to support your busy RA department, we will be delighted to help.

or call +44 1624 672777