Drug Labelling Review
DSA Regulatory Consultants can also handle the associated review of product labels to ensure compliance with Canadian labelling regulations as found in the Food and Drugs Act (FDA).
All labelling materials must be compliant with Canadian Regulations and the marketing authorization for the product including:
- Package labels
- Product inserts
- Product monographs
Our Canadian Regulatory services include pre-approval label reviews or label development to guide and advise you on changes to labelling which will help maximize claims and/or expedite product approvals. DSA also offers post-approval label reviews to ensure compliance with the marketing authorization or to help identify where supplemental filings to Health Canada may be required.