Getting a new drug approved by the regulatory authority is as important as the discovery of the new molecule. Our regulatory solutions help to advance drug development, submissions to regulatory authorities and ensure compliance throughout the product life cycle. Services include regulatory strategy, intelligence, submissions and due diligence. Our expertise covers many therapeutic areas and various technology and dosage forms.
Specific projects may include any one or all of the following: regulatory intelligence, regulatory pathway viability and requirements, pre-submission gap analysis, FDA meeting requests, preparations and presentations, preparation, publishing and submissions to FDA.