Drug Approvals & Regulations

DSA Consultants has almost 40 years of experience in pharmaceutical consulting. DSA Consultants offers a full range of regulatory affairs solutions for drug products ranging from regulatory submissions for drugs and biologics through to on-going compliance with Canadian GMP regulations.

For drug products, we provide consulting services in the area of Canadian Regulatory Affairs and Canadian Quality Compliance. The Food and Drugs Act (FDA) is responsible for providing the regulatory framework for the registration and sale of drug products in Canada. DSA Consultants handles all aspects of compliance with the FDA from drug registrations through to GMP compliance for both human and veterinary drugs.

“The Food and Drug Regulations define a “manufacturer” as someone who sells a food or drug under their own name or under a trade name that is controlled by them. This imparts much of the responsibility for compliance with the Regulations on the party who owns the rights to the product rather than the party who actually makes the product. When the Regulations impart responsibility on the party who makes the product, the term “fabricator” is generally used.”

DSA Consultants successfully achieves regulatory drug approvals from Health Canada. We obtain approvals for a full range of regulatory submissions to Health Canada and other directorates.

DSA works with clients as early as the CTA or Clinical Trial stage.
DSA advises firms on drug submission strategy for optimal drug approvals to help bring drugs to market sooner.
DSA provides ongoing submission management expertise through to NDS/NDA drug approval in Canada.
DSA prepares and files New Drug Submissions including DIN Applications with Health Canada through the Common Electronic Submissions Gateway (CESG).
DSA manages the Canadian submission process through to the issuance of a Notice of Compliance (NOC) or Drug Notification Form (DNF).
DSA manages the submission life cycle including change management and where required files post-approval changes via Supplemental New Drug Submissions (SNDS), Notifiable Change Submissions (NC) and Post-DIN changes (PDC).
DSA offers full eCTD services including electronic publishing/validation and submission through CESG using our validated account.
DSA handles QC Review of submissions prepared by your staff to validate the submission prior to filing through our own CESG Gateway account.