A multinational pharmaceutical client with niche portfolio, wished to increase sales in Europe for one of its established product. Three priority markets were identified by regional marketing and commercial teams.
An initial request was made to review the commercial strategy in regulatory terms, with particular focus on these markets, the inclusion of additional markets with impact on price, review time, launch dates etc. Legal basis, procedure type and choice of RMS were of key importance.
On agreement of a filing strategy, Regulink were asked to resource, project manage and compile the submission(s) with client stakeholders to meet the commercially planned launch date.
Due to the age of the established product’s registration dossier, initial filing legal basis and post-approval history, the expectation to fully update non-clinical, clinical and CMC aspects was known. It was essential to connect and work closely with multiple stakeholders within the Organisation and most critically with the manufacturing site. The client required a detailed risk assessment at the outset, since any Competent Authority request for additional studies would deem it a commercially unviable venture. The set up of a highly experienced and multi-skilled project team was essential.
