Navigating the regulatory pathway for products remains a challenge for many companies. Regardless of product sector (pharmaceutical, food and beverage, natural health product, cosmetic), the key five questions remain the same.
1. How is the product made?
Answering these five questions may require big budgets and a number of years in some cases. However, answering them appropriately and to a sufficient level of detail will advance a regulatory file.
Understanding the gaps and the feasibility of filling those gaps will allow budget to be spent wisely and in the correct areas. Too often, companies focus budgets in only certain areas and have an abundance of data in one area, while completely ignoring other key areas. It is critical that companies understand their commercialization pathway with the end goal in mind.
This end goal should be the marketing/health claim associated with the product. 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.
