Submission of Investigational New Drugs

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

IND or Investigational New Drug Applications are required for all new molecules that are eventually intended for use in human pharmacology products and have already been screened in animals. Once the legal status is changed to INDA under the FD&C it requires an application process which includes preclinical data which shows the product is safe for testing in humans; information on the manufacturer, composition and stability for manufacturing as well as protocols which will be used in the clinical studies to assess whether subjects will be exposed to unnecessary risks.