Product Submissions

We handle a full range of submissions to the Therapeutic Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD) and the Veterinary Drugs Directorate (VDD). Our range of submissions include:

Clinical Trial Application (CTA)
Clinical Trial Application Amendment (CTA-A)
Investigational New Drug Submission - veterinary drugs (INDS)
New Drug Submission (NDS)
Supplemental New Drug Submission (SNDS)
Abbreviated New Drug Submission (ANDS)
Abbreviated New Drug Submission - veterinary drugs (ABNDS)
Supplemental Abbreviated New Drug Submission (SANDS)
Supplemental Abbreviated New Drug Submission - veterinary drugs (ABSNDS)
Notifiable Change Submission (NC)
Drug Identification Number (DIN-A)
Drug Identification Number – Biologics (DIN-B)
Drug Identification Number – Disinfectants (DIN-D)
Drug Identification Number – Category IV (DIN-F)
Prescription to OTC Switch (Rx to OTC)
Administrative manufacturer name/product name change/licensing agreements (ADMIN)

Precursor Class A&B Submissions

The Precursor Regulations were approved in 2002. These regulations provide a framework for monitoring and controlling precursors and other chemicals frequently used in the production of illicit drugs.

There are two classes of precursors. Class A precursors are essential components of illicit substances. Class B precursors are mostly solvents and reagents that are often used in illicit manufacturing processes. Many of the noted precursors do have legitimate uses in many pharmaceuticals and cosmetics. The goal of these regulations is to enable Health Canada to control precursors, while at the same time be responsive to the legal uses of these chemicals.

If any of your currently manufactured products are formulated with either Class A or Class B precursors, we can help you determine if your products qualify for an exemption. If your products do not qualify for an exemption, we will help you obtain the required licenses and permits.

Market Access and Reimbursement Plans

Securing a formulary listing is crucial to the success of a new drug product. DSA has the expertise to prepare your submissions to the provincial drug plans and private payer plans. We prepare detailed CDR (Common Drug Review) Submissions to help you secure plan listings and ensure patient access to your drugs.

Domestic Substances List (DSL)

Pursuant to the New Substances Notification Regulations (NSNR), the Domestic Substances List provides an exhaustive listing of substances which are known to be in commerce for the manufacture of products regulated under the Food and Drugs Act. Products not on the DSL list are therefore subject to the NSNR. A submission is prepared to Health Canada and Environment Canada who jointly determine, based on our submission, whether the manufacturing or importing of the substance poses any risk to the health of Canadians or the environment. DSA can prepare your DSL submissions to help you gain approval for materials to be imported and used in manufacture.

Adverse Drug Reporting and PSURs

DSA can help you develop programs and procedures for Adverse Event Reporting and preparation of Product Safety Update Reports (PSUR). We can assist you with investigations for ADRs to determine if events are reportable. We can help you compile your PSUR or review prior to filing.

Contact us today to find out how we can help you spearhead your registration projects. For more information on services offered, click here to request a copy of our free brochure.

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