EUDRAC UK 10 years old today!
10 years ago, the EUDRAC UK team was starting work for its first client.
Since then, there has been significant growth in the team, the scope of client projects, the number of disease areas and product types.
Here is a top 10 list of the activities we have been involved in during this time:
- Winner of the prestigious Queen’s Award for International Trade 2018 based on exceptional growth
- Experts in product information - project managed >150 linguistic reviews of product information in the Centralised procedure and run a webinar with TOPRA
- Project managed, authored and eCTD published Centralised MAAs through to approval and post-authorisation life-cycle management with particular focus on orphan products
- Inspected for pharmacovigilance by BfArM – no critical or major findings
- Obtained PRIME designation for a client
- Led scientific advice meetings with EMA, UK, Germany, Denmark, Sweden, Netherlands, Austria, France, Spain
- Obtained and maintained several Orphan Drug Designations
- Provided CMC project management for commercial and clinical supplies manufacture and QC lab transfer
- Key team members for the UK launch of several products (promotional review, artwork, RMP educational materials, eMC)
- Provided global regulatory and PV intelligence service for clients to meet PV inspection obligations