Global Regulatory Compliance Support
The GFR team can help you avoid delays to market with our comprehensive understanding of the health supplements industry. We can assist you and your regulatory consultant with navigating the complicated regulations governing natural health products and functional foods in Canada. We also manufacture for companies world-wide and have experience working with international regulation consultants in meeting different government regulations and specific local consumer preferences.
Natural Health Products in Canada
Health Canada requires that all natural health products obtain a product license before they can be legally sold in Canada. GFR Pharma can assist your Regulatory Partner as they prepare the submission of detailed product information and specifications required in the Product License Application.
Dietary Supplements in the US
Finished dietary supplement products and dietary ingredients are regulated under the FDA in the United States. Supplements made in GFR Pharma’s GMP manufacturing facility can be manufactured in compliance with US GMP regulations. GFR Pharma is certified by Pro-Cert Organic which is recognized by the USDA National Organic Program.
Natural Health Supplements Globally
We have extensive experience working globally with clients in Asia, the Middle East and Europe. GFR Pharma is a Registered Dairy Processing Establishment which allows GFR Pharma products containing dairy to be eligible for interprovincial and international exports, including to the European Union.
Functional Food Regulations
When manufacturing functional foods, GFR Pharma can guide you in the selection of ingredients that fit within the food regulatory streams of Canada, the United States and other countries. Canadian functional foods are regulated by Health Canada and the Canadian Food Inspection Agency (CFIA).
American functional foods are regulated under the FDA regulations for conventional foods, food additives, and dietary supplements.
When designing labels for functional foods, one must be careful not to make therapeutic health claims unless recognized by the regulatory agency. Specific ingredients have pre-approved claims based on scientific studies that can be included on the labels.
Regulatory compliance has never been more important.
When you manufacture with GFR Pharma, you have access to GFR Pharma’s team of highly knowledgeable and experienced industry experts who can help bring your product to market in Canada, US and the world. Contact us today to get started!
We can work closely with your Regulatory Partner to provide information required by the certifying body which may cover ingredients, manufacturing processes, testing or other documents related to the quality aspects of your product.