Veterinary pharmaceuticals

Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science companies ensure that their companies comply with all of the regulations and laws concerning their business. The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products. Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs department. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role, for example, by considering the best processes to follow and enabling structured interaction with regulatory authorities. Regulatory Affairs is driven by good science and accordingly nothing remains static. Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targets and key claims have to be reviewed and adapted to regulatory guidelines and regulations. Consultations with the appropriate regulatory agencies, for example Scientific Advice procedures in the European Union (EU) or pre-IND meetings with the FDA, are milestones in product development. Regulatory professionals ensure that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right way and form. They develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents; they attend the meetings and manage all communication with the agencies. Since the regulatory environment is constantly changing the regulatory team provides advice on necessary adaptations to development plans and target product profiles