Pen & Tec Consulting Information

Pen & Tec Consulting is now operating under the Argenta brand as part of the world’s only global, combined contract research, development and manufacturing organisation (CRO/CDMO) dedicated to animal health and nutrition. Our regulatory affairs expertise in feed and food additives has been integrated into Argenta’s wider ‘molecule to market’ service offering. Pen & Tec’s 20 years of experience advising companies on the regulatory requirements for the European Food Safety Authority (EFSA), alongside Argenta’s existing expertise with the US Food and Drug Authority (FDA) and European Medicines Agency (EMA), means that we can offer customers in the animal health industry more comprehensive global regulatory affairs services. We offer advice and support at all levels and stages of registration projects, from initial planning and budgeting through designing and monitoring studies, reviewing data and preparing dossiers for submission. Alternatively, we can support internal departments when time and resources are limited so that your team can operate at maximum efficiency and meet corporate objectives. We can also advise on applications that have run into difficulty, helping them get back on track. Pen & Tec was founded in 2000 to help clients achieve European approvals. Since then, we have established a global network of associates, allowing us to offer regulatory advice in other leading global markets such as the USA, China, Brazil, India. Regulatory categories for food include: • Novel foods • Nutrition & health claims • Enzymes, additives & flavours • Food supplements • Food for special medical purposes Regulatory categories for animal feed include: • Feed additives • Feed materials and premixtures • Compound, complete and complementary feeds • Dietetic feed (ParNuts)