The requirement
Excellis was supporting a client’s planned EU launch of a novel oncology product through the Centralised Procedure, with an ambitious timeline. The programme required additional regulatory expertise for the labelling workstream.
RegConsult’s contribution
Excellis engaged Nik Wells and the RegConsult team to coordinate and produce submission-ready labelling. RegConsult provided regulatory knowledge and practical support within the wider delivery team.
The outcome
RegConsult responded promptly to requests and supported the preparation of submission-ready labelling. The client’s submission received approval.
“We couldn’t have asked for much more!”
Relevant support
This example brings together regulatory expertise, product information coordination and collaboration with a wider programme team.