REGULATORY OPERATIONS

Submission and management of global MAA’s/ BLA / NDA for pharmaceuticals and CE / FDA applications for medial devices. We file applications to notified bodies in EU and directly to FDA as required. We have significant experience of ATMPs, Orphan applications and Combination products.

The EU Clinical Trial Directive (2001/20/EC) concerning medicinal products for human use requires that the sponsor responsible for clinical trials in the EU must be legally registered in the European Economic Area. We at LE4D LTD offer a full Legal Representation Service for sponsors not established in the EU to comply with this Directive and for other markets around the world.

Global Operational management of pharmacovigilance including responsible person activities for clinical trials and MAA’s. We cover both pharmaceuticals and medical devices.

Management of all operational activities associated with licensed pharmaceuticals and medical devices.