IND Planning Resources to Get You There Faster
We are ideally positioned to support an efficient, rapid, IND submission to the FDA — for a review of the IND requirements, consult our Preclinical Assessment Planning Guide. Your submission needs to contain comprehensive information in three critical areas:
- Animal pharmacology and toxicology studies
- Manufacturing for producing the drug substance and the drug product
- Detailed protocols for proposed early clinical studies, including clinical investigators, necessary documentation and reviews, all within IND regulations
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept.
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