If you have an idea in mind but are not quite sure how to execute it we can help with the regulatory strategy that will take your business where you want. We can classify your product (generic, hybrid, full application, etc), choose the best submission scenario (DCP, national, MRP, parallel submissions in different territories) and guide you through the submission phase. We will communicate with the agencies and always keep you in the know on what’s happening.
We can assist with a range of regulatory activities including:
Do you know where you want your business to go to, just need help on how to get there?
We would be delighted to work with you on a regulatory strategy.
Workload Overflow & Continued Support
If you need sporadic support to help your busy RA department, we will be delighted to help.
Product Information Maintenance
Article 57 (XEVMPD) Maintenance
Preparation & submission of variations
Renewals, extensions, transfers & withdrawals
If you’re not looking for consultancy and would rather train your own team? We can provide a bespoke training solution that fits all of your needs.
We’re currently advising a number of clients in relation to navigating Brexit in both a ‘deal’ & ‘no deal’ outcome. Contact us to find out how we can help you.
or call +44 1624 672777