New Drug Submissions (NDS) and New Drug Applications (NDA)
New Drug Submissions (Canada) and New Drug Applications (U.S.) are required for the sale and marketing of pharmaceuticals to confirm the safety and efficacy of the product.
A comprehensive overview of the drug must be incorporated into the submission which includes clinical trial results, the ingredients of the drug, how the drug behaves in the body and how it is manufactured, processed, packaged and labelled.
At Nutrasource, we offer full-service consulting to ensure your new drug product has all the essential information for complete regulatory compliance in both Canada and the U.S., setting you up for success as you submit an NDS or NDA.
Looking for more information on New Drug Submissions or New Drug Applications? Contact a member of our team today or email us directly at firstname.lastname@example.org. You may also request a customized quote and we will contact you with details within two business days.