Case Studies

ERA helps non-EU pharmaceutical and biotech companies successfully access and maintain products in the European market through expert regulatory strategy, submission management, MAH services and lifecycle support.

Every regulatory project is different but the common thread across our work is helping clients reach the market faster. The case studies below highlight a selection of recent projects, from parallel UK MAA submissions and EU market entry for non-EU based companies through to post-authorisation strategy and complex workshare procedures. Click any of the tiles below to read the full case study.

Parallel Submission of Multiple MAA