In the regulatory services group our partnership with clients spans all phases of drug development. We routinely provide strategic advice and consulting for IND submissions all the way to NDA submissions and post-marketing trials. Cedent’s clinical trial management scope, experience and efficiency in regulatory consulting are strengthened through its integration with our expert clinical, medical writing and statistical teams.
We bring knowledge and experience to meet manufacturing, non clinical and clinical regulatory requirements. Providing regulatory project management, strategic and tactical advice and direction for drug development.We conduct critical reviews of key technical documents aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review.Coordinating and facilitating interactions with the FDA including serving as regulatory agent for US.