You have an exciting new product idea and are ready to take the leap and go to market. Before you start selling, however, it is important to make sure your product is the best it can be from a regulatory standpoint.
Carving out a strategic regulatory pathway for your formulation from the very beginning is key to market success and lasting brand credibility in the food and health products space. Here we describe the five key questions companies should answer before launching a new product.
1. How is the product made?
From a quality standpoint, it is crucial to know exactly how a product is manufactured and whether it meets the quality standards set out by the appropriate regulatory bodies. For example, are quality standards in place to ensure your product is safe, effective and of high quality? Does the site and its manufacturing processes meet these quality standards?
2. Where is the product made?
The country in which a product is manufactured will affect its regulatory pathway. For example, an imported product may be subject to different regulatory requirements than a product that was manufactured locally. Understanding these additional challenges at the beginning of your product development process will help avoid any regulatory surprises along the way.
3. What is the product?
In many cases, a product’s active ingredient(s) dictate the regulatory framework that must be adhered to in order to gain market access. Natural health products/dietary supplements, pharmaceuticals, foods and cosmetics all have different regulatory requirements and pathways, and it is possible for a product to fall into more than one category based on its ingredient content. Correctly and strategically determining a product’s regulatory classification early on will help maximize return on investment.
4. What do you want to say about the product?
Prior to taking a product to market, both the scientific and marketing teams should have a common view of the product’s messaging and the health/marketing claims you are hoping to make. All research and regulatory should flow from this objective and be reflected in the systematic literature reviews, pre-clinical work, clinical trials, stability experiments, characterization analysis and manufacturing quality systems. This approach will ensure budgets and time frames are optimized for successful product commercialization.
5. Where do you want to sell the product?
Finally, determining where the product will be sold will dictate which regulatory guidelines will apply. For instance, if a dietary supplement is manufactured in the United States but will ultimately be sold in Canada, it must comply with Health Canada’s regulations governing natural health products (which includes obtaining pre-market approval).
Once you’ve answered the five key questions, what is the next step?
For many companies, answering the five key questions can be a costly exercise in terms of both time and dollars. You may even reveal gaps in your manufacturing or R&D process that need to be filled before you can achieve your end objectives.
Enlisting a contract research organization can help you answer the five key questions strategically while helping you understand how to fill any gaps that may be discovered in the process. This will allow budget to be spent wisely and in the correct areas, as too often companies concentrate dollars in only certain areas while completely ignoring other important aspects.
Ready to answer the five key questions about your product? Our experienced regulatory team will help you map out a strategic plan for successful market entry, whether you are looking for U.S. or Canadian market access. Contact us today or click to get a quote now.
