Regulatory Support in Early Development


ICON can support you with your specific needs during early drug development, from dealing with non-clinical and CMC issues through to those in Clinical Phase I/II.

During this period we can assist you in the preparation of Investigator Brochures, INDs and EU Clinical Trial Applications, including IMPDs of all types and complexity. We can also arrange meetings with key worldwide regulatory authorities and support you in the preparation of the supporting documentation (including, for example, briefing dossiers). Our consultants have extensive experience in the preparation and submission of Orphan Drug applications and Paediatric Investigation Plans. We offer seamless transfer of clinical development to Phases IIB and III, and beyond.

With our expertise in early drug development, we are able to provide recommendations for best practice and strategic input as you move forward to maximise project and product potential.