NDA Regulatory Service

NDA Group is a world leading drug development consultancy. Our aim is to streamline the global development and commercialization process in order to accelerate patient access to important medical therapies. We support life science companies to identify and progress a clear development path, considering both regulatory and market access requirements to ensure new therapeutic approaches reach patients with minimum delay. We work together with our clients to address key strategic drug development challenges as well as prepare them for intense, critical regulatory interactions, such as FDA Advisory Committee Meetings, and major regulatory submissions. Our scientific expertise covers all major therapeutic areas. The advice you get from NDA is from real experts in the industry, many who have been involved in shaping today’s regulatory, payer and pharmacovigilance environment. Our team comprises over 150 consultants across Europe and the USA, supported by a network of over 1 000 scientific, clinical, regulatory and therapy area specialists and experts. On March 1st 2016 NDA merged with PharmApprove - the scientific communications firm in the US, world leaders in preparing and managing successful FDA Advisory Committee Meetings. NDA supported over 40% of the new medicinal products that were approved in the EU during 2013-2018. In addition PharmApprove's success rate for FDA Advisory Committee Meetings tops 80% in the same time period. With our support, you can cut the time and associated cost it takes to get your products to market, and keep them there.