Life-Cycle Maintenance
Post Licensing Activity and Project Management
Once your product is approved, the license is subject to post licensing activities to ensure that it remains safe and compliant with changing regulations. Updates to the marketing authorisation may also be made as the product evolves over time, and various strategies are used to extend its commercial value.
At Regulatory Specialist, we can provide regulatory support and project management for all your post-licensing activities from Variations, Renewals, Line extensions and including updates to the product information (SmPC and labelling).
The kind of regulatory support and management you need can be tailored to your specific requirements so that you can choose to have just ‘light touch’ where we act in an advisory capacity or ‘full package’ where we become your regulatory support arm and provide an end-to-end lifecycle maintenance service.