Globalisation has changed the way new medicines are developed and brought to market. A Parallel Scientific Advice (PSA) program, shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), provides a mechanism for global experts to concurrently engage with sponsors on key topics during the product development phase.
The benefits? They include new opportunities to optimise product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies, say officials.
Companies in the animal health industry with global ambitions can use the parallel approach to develop and launch new products simultaneously in Europe and the USA. Establishing a parallel approach and proactively engaging with regulatory agencies in both markets early in the product development journey could deliver real benefits.
“Often, companies with a new product idea need help in developing the best approach to get their veterinary medicine to market. They may be new to the animal health industry and do not fully understand the regulatory process or how to get started,” says Bill Zollers, Argenta's Head of Regulatory Affairs in the USA.
“Some prospective customers want a full one-stop shop service, while others a more ‘à la carte’ approach, with help at particular points in their product development journey. As companies look to develop products for launch in multiple markets, it makes sense to plan a regulatory strategy that supports this from the outset. Our Regulatory Affairs teams in the USA and European Union have the experience and expertise to help the sponsor navigate to a correct regulatory pathway.”
“Even the more established and experienced animal health companies approach us with problems they are facing – including regulatory challenges – when they do not have the internal resources or capabilities to solve them,” continues Cornelia Hüttinger, Head of Regulatory Affairs in Germany at KLIFOVET, part of the Argenta group.
As well as having strong regulatory expertise for veterinary medicines, Argenta can now also provide specialist advice on the best regulatory approaches to take for feed additives in the European Union, following the acquisition of Pen & Tec Consulting earlier this year.
Laura Payo Lewis, Pen & Tec Consulting's Regulatory Affairs Director, Animal Nutrition in Spain, says: “Frequently, assistance is sought to help guide the decision-making process for registering feed additives. Our experts can explain in detail the different routes that can be taken and the implications, such as those related to intellectual property protection or permitted claims.”
Whether you need regulatory expertise to support the development of a veterinary medicine or a feed additive, Argenta offers a broad range of services to help. Our teams in Germany, Spain and the USA have a proven track record with the European Food Safety Authority (EFSA) and the EMA, as well as national competent authorities in the European Union, and the FDA Center for Veterinary Medicine (CVM), the Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA) in the USA.
Contact us to find out more about how we can help you.