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Your partner in new drug R&D
Chart: 'New Drug Development Stages'

New Drug Development Master Plan preparation

Bio-Assistance prepares customized new drug development Master Plans. Each Plan contains sections on the chemistry, manufacturing, and controls (CMC), non-clinical and clinical development studies and regulatory strategies enabling filing of an application for the Marketing Authorisation (MAA) to European Medicines Agency (EMA) and a New Drug Application (NDA) to the US Food and Drug Administration (FDA).
The average cost of the Plan is US$4,000 (€3,500), depending on the amount of data compiled by the client.

Bio-Assistance prepared in the past Master Plans for the development of new drug candidates for the management of cystic fibrosis, psoriasis, atopic dermatitis, asthma, frailty and protein-energy wasting in patients with chronic kidney disease, a monoclonal antibody for the radionuclide imaging of myocardial necrosis, pain relief, probiotics, and biosimilar antibodies.

If you are interested, please specify your needs in an e-mail: