New Drug Submissions (NDS) and New Drug Applications (NDA)

Companies looking to launch a new pharmaceutical drug in Canada must first file a New Drug Submission (NDS) with Health Canada’s Therapeutic Products Directorate (TPD). In the U.S., a New Drug Application (NDA) must be submitted to the FDA. These regulatory filings are required to confirm the pharmaceutical’s safety and efficacy before it reaches the marketplace.

NDS and NDA submissions contain a comprehensive overview of the drug, including its active ingredients, pharmacokinetics and pharmacodynamics, and how it is manufactured, processed, packaged, and labelled.

We offer full-service consulting to strategically position your pharmaceutical submissions for success from the start. Our regulatory team will ensure your new drug meets all the essential information needed for regulatory compliance in both Canada and the U.S. while considering future development and positioning opportunities.

Learn how we can help you successfully bring your pharmaceutical to market.