Drug Approvals & Regulations
DSA Consultants has over 25 years of experience in pharmaceutical consulting. DSA Consulting 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.
- We work with clients as early as the CTA or Clinical Trial stage
- We provide ongoing submission expertise through to NDS/NDA drug approval in Canada
- We file New Drug Submissions or New Drug Applications with Health Canada
- We manage the Canadian submission process through to issuance of a Notice of Compliance or NOC including post-approval changes
- We also handle QC Review of submissions prepared by your own staff
- We spearhead the entire registration package
- We advise firms on drug establishment licensing options, so that upon product approval, firms can quickly and compliantly bring products to market
Contact us to find out more about our regulatory consulting services or download a free copy of our DSA Whitepaper on marketing a health care product in Canada.
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