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 over 20 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 specifi c 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.
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.
We prepare and file drug submissions to the following:
- Therapeutic Products Directorate (TPD)
- Biologics and Genetic Therapies Directorate (BGTD)
- Veterinary Drugs Directorate (VDD)
- Provincial Formularies
We prepare a full range of drug regulatory submissions for product licensing in Canada:
- Clinical Trial Application (CTA)
- Clinical Trial Application Amendment (CTA-A)
- Investigational New Drug Submission
- 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)