ARTICLE FEED & ADDITIVE MAGAZINE May 2024 81 submission, but only if it meets standards set out in the guidance. If you partner with an organisation with both development and regulatory capabilities, they can easily coordinate on specific data requirements, thereby helping to de-risk and streamline development processes in line with regulatory requirements. CRO/CDMOs can also help with identifying correct product categorisation, informing on realistic timelines at each stage of product development, and providing insight to changing guidelines. Additionally, if a developer is seeking approval in both the US and EU, guidance from partners with experience in both regions may provide information on overlapping requirements and how to streamline costly testing processes. What’s more, animal health CRO/CDMOs can ensure quality standards are met throughout the product development cycle and that the product is correctly characterised when the final formulation is established. In addition to adhering to required safety and GMP standards for manufacturing, CRO/CDMOs can also assist in identifying appropriate test sites and organise patient enrolment, minimising the risk of delays to already lengthy safety and efficacy/utility study periods. PLAN AHEAD AND PARTNER TO ENSURE SUCCESS Navigating the regulatory landscape for animal health and feed additive products can be a daunting task, but it is necessary to ensure quality, safety, and efficacy/utility. Although the road to regulatory approval can be difficult and costly, the benefits of bringing a new product to market are clear: happier, healthier, and safer animals. To overcome the numerous regulatory challenges and ensure a smoother path to approval, product developers must take a proactive and strategic approach. This includes planning early and integrating compliance measures into the product development process, as well as partnering with animal health CRO/CDMOs with expertise in regulatory affairs. By working closely with these experts, product developers can ensure that they meet all regulatory requirements and avoid potential setbacks, ultimately accelerating time to market and enhancing product success. About Dr. Bill Zollers Dr. Bill Zollers, Head of Regulatory Affairs at Argenta, has extensive experience in all facets of veterinary drug development new product registrations within the US and Canada. In his 30+ years, he has led several cross-functional teams to help navigate over 20 veterinary product approvals. During this time, Dr. Zollers has held numerous positions in animal health industry trade organizations, and served on many committees, subcommittees and working groups. Dr. Zollers earned his PhD degree from the University of Missouri. He joined Argenta, a global CRO and CDMO dedicated to animal health, in February 2020 and is responsibility for oversight of regulatory consultation for drug sponsors. About Dr. Cornelia Hüttinger Dr. Cornelia Hüttinger is the head of Regulatory Affairs Department at Argenta Munich, responsible for general strategic advice, registration, and regulatory life cycle activities for the registration of feed, feed additives, biologicals, and veterinary medicinal products. Dr. Hüttinger studied veterinary medicine at the University of Munich and did her thesis in oncology. Before joining Argenta she did Internship Programme at the University of Veterinary Medicine in Vienna and worked as assistant veterinarian in a Small Animal Clinic near Munich. About Laura Payo Lewis Laura Payo Lewis holds a Master's degree in Biotechnology from the University of Salamanca. For over 12 years Laura has been working with a variety of projects involving additives for pets and livestock in the EU and other leading markets. She developed a passion for regulatory affairs by helping companies successfully bring new feed additives to market and ensuring market continuity. Laura is currently leading the Animal Nutrition Regulatory department at Argenta Barcelona.
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