• Advising on the most appropriate route for submission throughout Europe (national, Decentralised, Mutual Recognition or Centralised), considering the pros and cons of each
• Advise on scenarios around life-cycle planning
• Regulatory life-cycle management, including:
– Type I/minor variations
– Type II/major variations
– Renewals
– Periodic safety update reports
– Line extensions
– Deregistration/discontinuation
• Handling of responses to questions from health authorities
• Packaging activities such as packaging change requests based on labelling changes, artwork updates, and mock-up preparation
• Translation activities
• Approval management
• Handling of post-approval commitments
• Providing regulatory intelligence with regard to new or revised legislation
Processes are in place to make sure that safety changes and other changes get communicated to the client’s global regulatory affairs, that there is regular liaison with the affiliate as required, and that any deficiency letters get quickly reported to headquarters.
KPIs are established to determine whether project objectives are being met. KPIs include:
• Communication via meetings, status reports, and progress reports
• Evaluation of regulatory submission timelines
• Quality of information collection and application content
• Packaging materials that reflect current requirements for specific individual markets
• Tools for archiving of relevant documents in the client’s database