Natural health product site licence applications
At Eadcor we provide the following:
- Management of supply chain strategy for facilities involved in Canadian natural health product site licence application.
- Assessment of all facilities for compliance with the Canadian Natural Health Products Good Manufacturing (GMP) guidelines.
- Creation of standard operating procedures (SOP) required for facility operations.
- Preparation and submission of natural health product site licence applications.
- Application preparation for a Health Canada recognized foreign site reference number.
- Submission of site licence amendments and site licence renewals.
Natural Health Product Licensing
We can ensure your products are compliant with all requirements of Health Canada’s Natural Health Products Regulations so you can get your products to the Canadian market as quickly as possible.
- Review your natural health product labels for sale in Canada.
- Assess formulations for eligibility under the Canadian natural health products regulations.
- Review finished natural health product testing programs for compliance.
- Prepare and submit your natural health product licence applications.
- Manage natural health product licence applications from start to approval.
- Provide French language translation support.
- Submit of post-licence changes for natural health products (product licence amendments).
- Review your advertising plans for dietary supplements and natural health products in Canada.
Pharmaceutical products licensing with Health canada
Our regulatory affairs services for drug products in Canada work with you to:
- File your drug submission applications to Health Canada for approval.
- Manage all post-approval product changes for pharmaceutical products in Canada including label safety assessment updates for product monographs.
- Provide solutions for you to meet the requirements of Good Manufacturing Practices, Division 2 of the Canadian Food & Drug Regulations including Drug Establishment Licensing (DEL).
- Assist with third-party product release for your pharmaceutical products in Canada.
- Oversee registration of your Canadian clinical trial sites so they comply with Health Canada’s Food & Drug Regulations, Division 5.
Call Us or Email to know how we can get your facility or product ready for licensing by Health Canada!