Biologics: How to get your biological product to market and keep it there

Sub-Title : How to get your Biologic Product to Market and Keep It There. The information provided in this book is to close the gap that exists in getting a product from proof of concept stage to commercialization (a Licensed product).Details on production, control and regulation of biologics include pre-clinical, GLP, clinical GCP and GMP. Validations of premises, equipment, processes and methods are covered. Detailed suggestions are provided to comply with inspection observations concerning GMP and product requirements. How to fill in Clinical Trial Applications and New Drug Submissions as to reviewer comments is also covered. CTD requirements as established by ICH are thoroughly examined. Prequalification requirements by the World Health organization (WHO) for vaccines and how to get approval are included.