Evaluate Drug Submissions for Canada

When I evaluate drug submissions it is basically for the Canadian market. However, I am famaliar with other international markets like the US and European markets.

Here is what is covered when evaluating drug submissions for vaccines and other biologicals ...

• Documents for pre-licensure meetings with the regulatory authorities
• Clinical Trial Application (pre-clinical, clinical and quality requirements)
• New Drug Submissions - quality review of preclinical and chemistry and manufacturing sections as according to requirements of the Common Technical Document (CTD) of the International Conference on Harmonization (ICH)
• Drug substance, drug product and facility; including all aspects of production, validation, testing and specifications for inprocess and for intermediates, final bulk and final product; stability and expiration dating
• Labelling
• Product Monograph
• Certified Product Information Document
• Changes to marketed drugs applications (Supplemental New Drug Submissions, Notifiable Changes and Notice of change)
• Release protocols and test data for consistency lots and marketed lots
• International lot release for World Health Organization

Phone me to discuss all aspects of evaluating documents and drug submissions or return to home page.