This business case is about IND preparation and submission.
A small European biotech company focused on drug discovery and development, investigating the clinical potential of a novel compound (newchemical entity) in various autoimmune diseases, interested in engaging with the FDA and submitting an IND.
The product had: a complete set of nonclinical studies, completed phase I and phase II clinical studies, as well as available IMPD and IB.
The project presented the following challenges:
The activities performed by Asphalion included:
Successful results regarding:
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