The areas in which we can make a difference include:

• Preparation of the components of the Common Technical Document (CTD) – Chemistry, Manufacturing and Controls (CMC) and Non clinical documents: Non Clinical Overviews, and Summaries (Modules 2.4, 2.6) & Non-clinical Assessment Report (module 4)
• Prepare the ecotoxicological dossier (module 1.6)
• Preparation of Marketing Applications (New, Variations, Renewals)
• Submission to the Health Authorities (National, CP, MRP & DCP)
• Compilation of documentation for Marketing Authorisation