Our committed regulatory affairs professionals bring extensive experience and expertise when it comes to handling your pharmaceutical submissions with Health Canada, whether your product label requires a review, amendment or creation of a new one.
We can support your entire registration process from initial submission preparation right through to the review process. Timely approvals in part requires having the right team on your side that understands the issues that impact the review of new drug submissions; that stays on top of current regulations that may affect the development and approval of your products, as well changes to the regulatory landscape that may challenge efforts.
Solutions and Services
We prepare and file the following pharmaceutical regulatory submissions:
New Drug Submissions (NDS)
New Drug Submissions with Health Canada for brand-name patented drugs include preparation and filing scientific information about product safety, efficacy and quality, claimed therapeutic value, conditions for use and side effects, results of pre-clinical and clinical studies, production details, packaging and labeling information.
Abbreviated NDS (ANDS) for generic drugs
The ANDS submission involves submitting data that shows how the generic product performs compared with the brand-name product. It must be shown to be as safe and efficacious as the brand-name product and must meet the same quality standards as an NDS. Submission includes scientific information, production details, packaging and labeling, and comparative bioavailability studies showing how the generic drug can deliver the same amount of medicinal ingredient at the same rate as the brand-name product.
Supplemental NDS (SNDS) for already-authorized drug products
Includes changes to dosage form or strength, formulation, manufacturing method, labeling, recommended route of administration or to expand the claims or conditions of use (indications).
Drug Identification Number (DIN)
Review and application filing for Drug Identification Number for products in Canada that do not meet the definition of a ‘new drug’. However if the substance for use as a drug has already been available for sale over a sufficient time period and quantity to establish its safety and effectiveness.
Therapeutic Product Directorate (TPD)
The Therapeutic Product Directorate in Canada is part of the DIN application. An acceptable label design is required to show the TPD that the product is not going to be marketed in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, efficacy, quantity, composition or safety.