A critical part of the laboratory research process is In vivo studies conducted in animals for the evaluation of new medicines. In biomedical research, animals have contributed to lifesaving treatments in the areas of cancer, diabetes, vaccines, high blood pressure, and neurological disorders, just to name a few. In food and fiber or agricultural research, animals have helped provide solutions in areas such as veterinary medicine, parasite control, analgesia, and ensuring safe and affordable food supplies globally.
Prior to start of any research on animal, replacement of animals with alternative non-animal methods including the application of in vitro (test tube) systems or in silico (computer based) systems as well as the use of a species lower in the phylogenetic scale, such as using the nematode instead of sheep needs to be done. Various other points of consideration are reduction is defined as the reduction in the number of animals used by the application of good experimental design and the proper statistical methods.
Pharma consultants provide broad range of services for the products regulated by FDA for animal medicines, few of them are determine the regulatory category (drug, food additive, device, biologic, or “other”) of investigational products for use in animals, Strategic and product development planning, Provide training about the FDA animal drug approval process, Organize meetings and negotiate with FDA, Draft and edit documents for FDA review, Assist in regulatory activities associated with product approval for, New Animal Drug Applications (NADA) and, Abbreviated New Animal Drug Applications (ANADA - generic animal drugs), Assist clients in choosing and working with Contract Research Organizations to run toxicology, target animal safety, and effectiveness studies, Monitor safety (GLP) and effectiveness (GCP) studies, US Agent for foreign companies.
Pharma and animal healthcare consultants provides services in identifying regulatory approval requirements, preparing and submitting protocols, arranging conduct of the studies, preparing and submitting the entire NADA, ANADA, or veterinary biologics license application, and conferencing with FDA or USDA for product approval. They also assist with individual stages of their projects, monitor specific studies, support data analysis, or assist with document compilation and report writing.