NDA is a leading regulatory and drug development consultancy, providing Biotech and Pharmaceutical companies of all sizes with advice on the shortest and most economic development path to regulatory approval and patient access.
Our team of over 150 employed Consultants, working out of key sites in Europe and the United States, is complemented by a specialist Advisory Board, comprising the most experienced and well respected experts from regulatory agencies, scientific committees and HTA bodies.
Together, we provide operational support and strategic advice to clients from early drug development through the complete lifecycle of their products, in all therapeutic areas.
In regulatory, we cover CMC, non-clinical, clinical as well as procedure and submission management. Health technology assessment, pharmacovigilance and drug/device combination products are additional areas we focus on.