Drug Regulatory Submissions

The Health Canada regulatory process can seem like a maze whether your company is a multinational with extensive regulatory experience or a company that is newly emerging in the marketplace. DSA helps you navigate this maze by tailoring our strategic regulatory solutions to your needs. DSA Consultants has almost 40 years of experience in Canadian Regulatory Affairs consulting and obtaining drug approvals for our clients.

Initial meetings and conversations with clients are used to develop regulatory strategies for a specific project. Our goal is to develop a regulatory strategy that meets both client needs and Canadian regulatory requirements. We then work with the client to implement these strategies.

DSA Consultants offers a full range of consulting solutions to facilitate Canadian registration of your human or animal drug products. A DSA Regulatory Affairs Consultant can handle the entire registration process from submission preparation through to managing the review process with Health Canada. We can also review submissions prepared by your staff to provide a critical review with the goal of identifying deficiencies so that Health Canada’s review is more streamlined. If you require assistance with eCTD submissions including validation or e-publishing, DSA can manage your submission filing through the CESG (Common Electronic Submission Gateway) with our validated account.

The Food and Drugs Act (FDA) provides the regulatory framework for the registration and sale of drug products in Canada. DSA Consultants handle all aspects of compliance with the FDA from drug registrations through to drug approvals and then post-approval changes.

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We prepare and file drug submissions to the following:

Pharmaceutical Drugs Directorate (PDD)
Biologics and Genetic Therapies Directorate (BGTD)
Natural and Non-prescription Health Products Directorate (NNHPD)
Veterinary Drugs Directorate (VDD)

We prepare a full range of drug regulatory submissions for product licensing in Canada:

Clinical Trial Application (CTA) and Amendments (CTA-A)
New Drug Submission (NDS)
Supplemental New Drug Submission (SNDS)
Abbreviated New Drug Submission (ANDS)
Supplemental Abbreviated New Drug Submission (SANDS)
Veterinary Submissions

Veterinary New Drug Submission (VNDS)
Veterinary Abbreviated New Drug Submission (VANDS)
Veterinary Supplemental New Drug Submission (VSNDS)
Veterinary Health Product Applications (VHP)

Notifiable Change Submission (NC) including Level III Post Approval Changes
Drug Identification Number (DIN-A) including Post-DIN Changes (PDC)
Drug Identification Number – Biologics (DIN-B)
Drug Identification Number – Category IV (DIN-F)
Prescription to OTC Switch (Rx to OTC)
Biocides Application (DIN)
Administrative manufacturer name/product name change/licensing agreements (ADMIN)