Our Experience

HLS’s experience of undertaking full development for new active substances is far more extensive than any other contract research organisation. HLS has been responsible for the management of full development programmes on six new compounds submitted for EU Annex I listing:

Duration of programmes from initiation at HLS to submission has been from 4.25 to 6 years.

These programmes were supplemented, as required, to achieve registration or import tolerance elsewhere in the world, including US, Japan, South America and Australia.

In addition, as part of the EU re-registration process we have devised and managed programmes of data gap studies, together with the associated risk assessments and dossier preparations and submissions, for twelve of the List 1 to 3 compounds.

Our involvement continues with post-submission support for our clients, in terms of dealing with regulatory questions and the management and conduct of further work for national registrations.