Eadcor operates internationally from Ottawa, Canada with the main focus on Middle East and North Africa. Eadcor's consultants have many years of experience in the pharmaceutical, veterinary or medical device industries. Experience that has seen most of the problems that can occur in facility design, scale up development and manufacturing. Experience that can prevent you making mistakes, or solve them if it is too late.
As consulting professionals it is our job to stay up to date with current regulations so that we can be sure our customers comply.
Have you got time to read them all, are you sure you are compliant?
Your Path to GMP...
The Canadian system of pre-market licensing for natural health products (dietary supplements) tends to be surrounded by a cloud of mystery for groups looking to sell their products in Canada. The two types of licenses required before sale are distinct in what they cover, and the licenses may be owned by different parties, which results in further bewilderment for many candidates.
The submission of a product license application to Health Canada will cover the actual product, what is in it and how it is used. Both Canadian and non-Canadian companies may apply for a product license applications for a natural health product and receive a Natural Product Number (NPN).
However for the second type of license, a natural health product site license, only Canadian companies are eligible to apply. The site license process is in place so that Health Canada can ensure that a Canadian company rather than a foreign company oversee and attest to GMP compliance, as required by Part 3 of the Natural Health Product Regulations.
The Canadian applicant will complete the necessary documentation to demonstrate GMP compliance at all facilities involved in their supply chain including the Canadian facility that is importing the products, the non-Canadian facility that manufactures the products, and any additional location involved in packaging and labelling the products. Each location listed on the license is required to provide the Canadian applicant with their GMP evidence for the site license application. There is often multiple buildings listed on a single site license application.
Having a clear understanding of the distinction between the two types of natural health product licenses and who is permitted by Health Canada to apply for them may help reduce the time to market and increase the chance of success during the application stage.
- Eadcor prepares the Site License Application Form and the “Quality Assurance Report” that needed by Health Canada to receive the site license.
- Eadcor offers clients complete turnkey solutions including:
- We provide all the needed GMP SOPs
- We provide blank templates (records) as per Health Canada requirements.
- We provide many types of training certificates including Natural Health Products GMP certificate, Dietary Supplements GMP certificate (USA New Rules), Drug GMP, and Good Documentation Practices (GDP) certificates.
- Eadcor conducts “Third Party Audit” to assess the degree to which the facility is fulfilling the applicable GMPs requirements.
- Eadcor awards the facility a “Certificate of GMPs Compliance”, if the site found to be fulfilling the latest Health Canada GMPs requirements.
Our record helping small and medium size facilities to obtain Health Canada site license speaks for itself.