Regulatory Affairs

The greatest mistake that companies make when entering the pharmaceutical market is to think that they can shortcut the process or negotiate on their own with regulatory bodies in the EU, Canada, the FDA, or Japan. It is only through the assistance of experienced professionals that is it possible to avoid initial errors that can slow or totally derail an otherwise promising research programme. Through our knowledge of Good Agricultural Practice (GAP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), and experience with the governmental agencies that oversee pharmaceutical development, ICCI can offer you the best opportunity to succeed in product development and launch to market with the fewest missteps and wasted expenditure.