Regulatory Operations

Submission and management of global MAA’s.

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.

Management of post licensing activities.