Current Health Canada performance standards are at 250 days for approval of foreign sites.
- Regulatory Authority Inspection Report
- Certificate of GMP Compliance for MRA Countries
- Corporate or Consultant Audit Report
DSA recently filed a DEL amendment which was approved within much shorter timeframes by Health Canada; thanks to the hard work of our Regulatory and Quality Consultants.
Our client had a key manufacturing/packaging/labelling site which was about to expire and did not have evidence to provide to Health Canada. DSA was asked to send one of our Senior Quality Consultants to audit the firm and prepare the evidence package for Health Canada.
Our client was thrilled with the outcome – the site was approved within 120 days and approved with a 3 year compliance expiry.
The key to getting fast approvals is clearly understanding Health Canada expectations for a complete evidence package and making sure all open observations are addressed prior to submission. Within DSA we use a team-based approach. Our DSA Regulatory Consultants handle DEL amendments on behalf of our clients but we work with our Senior Quality Consultants to ensure that a complete and compliant package is ready for submission. This helps minimize any follow-up requests or communications with Health Canada and ensure that quick approval times are achieved for our clients.