ISSUE FOCUS FEED & ADDITIVE MAGAZINE September 2023 39 ings, as well as increased scrutiny from regulators. GEOGRAPHICAL NUANCES: UPHOLDING BRAND REPUTATION In addition to these common challenges, each territory has its own. For example, in Europe, the non-confidential parts of applications and the opinion reflecting EFSA’s findings are published and can be accessed by competitors and consumers alike. As a result, if the EFSA determines there is a toxicity risk, for instance, this information can become widely known and potentially damage the brand’s reputation. The consequences of this can be so great that some companies choose to withdraw EFSA applications to avoid this outcome. In these cases, although the brand’s reputation may not be damaged, there will still be wasted resources and efforts from having prepared the dossier and all the associated activities with it. PRE-EMPTING AND OVERCOMING REGULATORY CHALLENGES When carving your path to regulatory success, strategic planning from the outset is critical. It begins with identifying territories of interest. If a developer wants to sell their plant-based nutritional feed additive in both the US and EU, with meticulous planning, certain studies can serve approval requirements for both regions simultaneously — a strategic move that saves resources, time, and cost. What’s more, gaining approval in the US and/or EU can serve as a gateway to approval in other territories. For example, securing regulatory approval in the EU can expedite the process in countries like Turkey. In fact, the importance of strategic planning cannot be underestimated: fail to prepare; prepare to fail. As Laura described, “Strategic planning isn't just an aspect of delivering a successful product to market; it's the fundamental bedrock of the whole process. From identifying key territories to streamlining study designs for optimal approval in multiple regions, every move we make for our clients is strategic. Having a deep understanding of regulatory intricacies is like having a roadmap to success. By working with regula-
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