Drug Approvals & Regulations

DSA Consultants has over 20 years of experience as pharmaceutical consultants. DSA Consultants offers a full range of regulatory affairs solutions for drug products ranging from regulatory submissions for drugs and biologics through 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.

On the Regulatory Affairs stream, 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
  

On the GMP Quality stream, DSA Consultants have been leaders in Canadian Drug Establishment Licensing since the Establishment Licensing regulations were first introduced in 1997. We manage all aspects of the licensing process from application to Health Canada inspection and post-approval compliance with GMPs (Good Manufacturing Practices).

For more information on services provided for drug products:

• Regulatory Submissions
• Establishment Licenses
• Quality Control/Quality Assurance
• Mapping & Validation
• GMP Audits
• Documentation Review
• Standard Operating Procedures
• Complaints
• Annual Product Quality Reviews
• GMP Training

Contact us to find out more about our drug regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.