Remaining compliant with the regulatory framework defined throughout the marketing authorisation is a huge challenge where consistency, clear communication and fact-based decisions are needed. Our consultants specialised in regulatory affairs are strong data gathering, report compiling, communication and providing strategic advice towards any regulator during the phase of a marketing authorisation process.
Our expertise in regulatory affairs entails the following:
- Supporting the entire submission process, from IND submissions to gaining global health authorities’ approval to lifecycle management
- Follow-up on post-marketing activities, including writing notifications, variations, and label/leaflet changes.
- Providing answers towards authorities’ queries, including scientific, manufacturing, compliance and legal.
