Drug Regulatory Submissions

Q&R Regulatory Affairs consultants have extensive DIN submissions experience, having worked on behalf of many companies.

We work with our clients through the entire registration process from submission preparation through to managing the review process with Health Canada including:

– Review of product claims and formulations providing advice and guidance.
– Complete all of the required paperwork and submit product application to Health Canada
– Review of the submission to ensure an accurate classification is received back from the regulator
– Provide a checklist of all of the requirements to fulfill in order to distribute your product in Canada
– Help launch the product and/or answer any questions and provide guidance as to the next steps.
Drug regulatory submissions prepared by Q&R for product licensing in Canada:

New Drug Submission (NDS)

Supplemental Abbreviated New Drug Submission (SANDS)

Supplemental New Drug Submission (SNDS)

Supplemental Abbreviated New Drug Submission – veterinary drugs (ABSNDS)

Abbreviated New Drug Submission (ANDS)

Notifiable Change Submission (NC)

Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.