Upstream JCA readiness in practice
A featured example of the upstream EU JCA readiness work we do with rare disease, ATMP and specialty teams – designing internal architecture, building cross-functional alignment, and embedding tools that get used at the point of need. Other engagements are confidential by client preference; we’re happy to discuss directly.
01
EU JCA Patient Playbook for a Mid-Size Biotech
EU JCA READINESS, DESIGNED FOR AFFILIATE TEAMS
Affiliates sit at the end of the JCA chain – small teams, no specialist expertise, under pressure when timelines run. A mid-size biotech preparing its first specialty asset for EU launch wanted to be ready for that pressure well ahead of formal scope.
We worked with the Market Access Director and a cross-functional task force to design a modular playbook around behavioural principles — and helped roll it out across central and affiliate teams so it became something they reached for at the point of need, not a document they had to remember existed.
