A proper IND application must contain robust information in three broad areas[1]:

1. Animal pharmacology and toxicology studies that provide enough data to assess whether the product is safe enough to be used for initial testing in humans. Any previous experience with the drug in humans is also included.
2. Manufacturing information showing the composition of the compound, the manufacturer, the stability and the controls that were used to manufacture the drug. 
3. Clinical protocols and investigator information: The detailed protocols allow for proper risk assessment of the initial phase trials. The information on the qualifications of the investigators to assess they are qualified to fulfill their clinical trial duties. 

Submitting an IND application can seem like one of the most demanding and stressful steps in your compound’s journey. With PharmaLegacy by your side, no need to worry. With over 400 FDA / CFDA IND filings in our portfolio, the deep experience of our pharmacology experts, and our unwavering work ethic, your compound will make it all the way to the finish line in no time!