A well-conceived and executed IND package/CTA-enabling preclinical program will provide you with a detailed assessment of your drug candidate and the most cost-effective and timely pathway to filing. Before a new drug candidate can be administered to humans, a series of preclinical studies should be conducted to characterize the compound. IND enabling studies are integral to the IND package and must be included in the submission. Key components of the data package include pharmacology, toxicology and safety pharmacology, ADME, and CMC sections of the submission.
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