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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Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.