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Pharmaceuticals

Expert drug submissions advice and support

SERVICES →

Pharmaceuticals

Expert drug submissions advice and support

We provide extensive DIN submissions experience and expertise to review, amend or create your product’s labeling as required for the submission.

Our committed professionals deliver the highest quality submissions to Health Canada.  We do this by understanding the issues that impact the review of new drug submissions; stay on top of current regulations that may affect the development and approval of your products, and changes to the regulatory landscape that may challenge your efforts.

Solutions and Services

New Drug Submissions (NDS)

Submissions for new brand-name patented drugs include scientific information about the product’s safety, efficacy and quality, its 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)

For products that do not meet the definition of a ‘new drug’ however the substance for use as a drug has already been sold in Canada over a sufficient time period and quantity to establish its safety and effectiveness.

Therapeutic Product Directorate (TPD)

The Therapeutic Product Directorate 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.

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