NCBiologics Consulting provides high quality and customized expertise related to industry standards and FDA, EMA, and ICH regulations as these apply to the research, development and commercial production of biologic therapeutics and related technologies. Natalie Cohen guides biotechnology and pharmaceutical companies to analyze, determine and implement the most timely and efficient CMC and bioanalytical strategies to steer a molecule from discovery throughout development, and meet the regulatory requirements necessary to obtain marketing approval on the worldwide market. The services include a wide range of regulatory, CMC, and bioassay development support for product characterization, batch release testing, preclinical and clinical testing, regulatory submissions and post-marketing compliance.
Bioassays are the foundation by which analytical control strategies for biologics are built, and are required throughout biologics development, from research to final product. While the FDA and ICH regulatory guidelines provide a necessary framework for biotechnology product development and analytical testing, practical regulatory and operations experience is imperative to successfully navigate through the regulatory maze to the market.
Looking for answers? What bioassays are necessary for your product? When, where and how to validate your bioassay?
NCBiologics Consulting helps you get your biologic to market and keep it there