Toronto-based CK Nutritional Ingredients, Canada’s leading supplier of innovative science-based raw materials to the natural health products industry, is pleased to affirm its commitment to the preparation and submission of Master Files for the majority of its products.
Master Files are information dossiers that contain quality, safety and efficacy data on a specific ingredient. They can be prepared with or without the assistance of a regulatory consultant and are submitted to the Natural Health Products Directorate (division of Health Canada), Canada’s governing body for vitamins, dietary supplements and natural health products. Formulators of Natural Health Products can then cross-reference the Master File in their finished product license application, greatly lessening the demands on the company’s R&D, Q.A. and Q.C. staff, among other things.
Michael Chernyak, Managing Director of CK Nutritional Ingredients states, “The Canadian regulatory environment is a challenging one, and one that is placing increasing demands on developers of Natural Health Products. The preparation and submission of Master Files for many of our raw materials highlights our commitment to our clients – we want to do everything possible to support their efforts to get safe and effective government licensed products to market.” Jim Bornhold, CK Nutritional Ingredients’ Director of Sales agrees, “A growing number of our clients are preaching the value and importance of ingredient Master Files. CK is a firm believer in the partnership approach as relates to our clients, and the development of comprehensive Master File dossiers is one way for us to contribute to
the team effort.”
Twelve Master File numbers have already been secured, with several other dossiers in the works and expected to be submitted within the coming months. CK Nutritional Ingredients is also contemplating Master File preparation for a number of other ingredients in its product portfolio. Additional information can be obtained by calling Jim Bornhold at 905-760-1176, Ext. 223 or e-mailing [email protected].
About CK Nutritional Ingredients
Headquartered in Toronto, Canada, CK Nutritional Ingredients is Canada’s leading marketer of high-value nutraceutical raw materials supported by human clinical studies. For additional information please visit www.ckingredients.com or contact Michael Chernyak, Managing Director, at 905-760-1176, Ext. 222, or [email protected]
Source: CK Nutritional Ingredients