SPECIAL STORY 64 FEED & ADDITIVE MAGAZINE November 2023 Tailored guidance at every stage of the process Companies developing zootechnical additives have many excellent sources of regulatory guidance at their disposal (they can talk to trade associations, for example). But advice from such sources will typically be very general, rather than tailored to a company’s specific product or situation. A dedicated regulatory consultant with deep experience, on the other hand, will be able to carefully interpret guidance documents in the context of a product, crafting tailored recommendations to help meet a company’s specific needs and goals. Importantly, because guidance from organizations such as trade associations is typically general, companies may still need more tailored consultation. This means that, for some developers, seeking general advice is little more than a poor use of time and resources. Avoiding common pitfalls, swiftly resolving issues Suitably knowledgeable consultants will also be able to advise developers on the best ways to avoid common and costly pitfalls throughout the entire regulatory process. “Consultants have a wealth of tips to help their partners sidestep potential problems,” noted Andrew. “This could be something as simple as including sensitive information only on the front page of a dossier, as opposed to on every page footer — the latter increasing the risk of GDPR slip-ups. Most companies won’t give small details like this much thought, but the time saved over the entire application process can be an edge that gets you to market faster.” What’s more, experienced consultants will be able to help swiftly resolve issues if they do arise. Having become deeply familiar with how regulators work, some consultants have developed a good understanding of how regulators will respond in certain scenarios, meaning they can help developers anticipate and best work through potential roadblocks or answer any complex questions. Better anticipate, and prepare for, regulatory changes As highlighted above, continual regulatory change can be a daunting barrier to success. But knowledgeable consultants that are deeply embedded in the industry and have good networks with EFSA and the EC can anticipate regulatory changes and their impact. In cases where changes might mean more studies are required for a company’s product, consultants can help them adapt early to minimize costly disruptions. Likewise, in cases where upcoming changes are likely to require fewer studies, consultants can alert companies early enough to potentially avoid unnecessary stud-
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