IND Enablement

ind-enablement.pngOnce a potential clinical candidate is identified, Array embarks on a thorough nomination process based on a full set of product attributes and characteristics. Following nomination, GLP toxicity studies are conducted and an IND filing date is set. 

We use a "fit for purpose” CMC approach, delivering API and drug product manufacturing processes appropriate to the stage of development, thus minimizing timelines and investment.

Array has all the resources necessary to produce IND-enabling cGMP drug product and includes expertise in Process Chemistry, Pharmaceutics, Analytical R & D and Quality Control.