REGULATORY STRATEGY

MAA or NDA or BLA APPLICATION

Global applications for MAA/NDA/BLA to deliver market access in the most efficient sequence considering EU, US, Asia, Japan, China and Latin America.

STRATEGY

This includes early access programmes, clinical trail strategy, importation and distribution solutions.

EU & NATIONAL SCIENTIFIC ADVICE

Scientific Advice and Protocol Assistance can be sought at any time during drug development. It is We provide comprehensive support to our clients guiding them through the process to obtain meaningful advice and guidance as part of their drug development programme.

ORPHANS/PIPS

We have extensive experience in planning and organising Orphan and PIP’s for clients.

SME SERVICES

LE4D LTD is a SME status holder and qualifying clients can be associated to our SME status. We are fully equipped to guide and explain the process to ensure we can achieve a positive outcome. Areas of expertise include ATMP’s, orphan, medical devices and combination products.