Health Canada

Health Canada – Overview

We provide regulatory expertise to support pharmaceutical, biotechnology, and medical device companies in obtaining product approvals and maintaining compliance with Health Canada requirements. Our services ensure smooth navigation of Canadian regulatory pathways, from development through commercialization.

Services

Abbreviated New Drug Submission (ANDS)

Submission for approval of generic pharmaceuticals demonstrating equivalence to a reference drug.

Preparation, submission, and review of ANDS for generic pharmaceuticals to ensure compliance with Health Canada regulations.
Support for addressing questions, deficiencies, and updates during the evaluation process.

New Drug Submission (NDS)

Comprehensive application for approval of a new drug, including quality, safety, and efficacy data.

Comprehensive preparation and submission of NDS for innovative drug products, including quality, non-clinical, and clinical data.
Continuous support for regulatory correspondence, review responses, and post-submission updates.

Clinical Trial Application (CTA)

Submission to regulatory authorities seeking approval to conduct clinical trials for a new drug or medical product.

Assistance with trial design, protocol submission, and ongoing amendments.
Preparation, submission, and ongoing maintenance of CTA applications to ensure compliance with regulatory requirements.
Continuous support for protocol amendments, safety updates, and regulatory correspondence throughout the trial lifecycle.

Drug Master File (DMF)

Confidential submission providing detailed information on the manufacturing, quality, and control of drug substances, excipients, or packaging materials.

Preparation and submission of DMFs for active pharmaceutical ingredients (APIs) and excipients.
Support for technical, regulatory, and safety updates, as well as responding to regulatory queries during the evaluation process.

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