Innovative and flexible technology for rapid and cost-effective approval of biosimilars to market. With over 30 years of experience in creating new drugs, chemicals, biologicals, and biosimilars, we are now creating a novel platform that guarantees the lowest cost and time to market—-We guarantee it. Novel 351k provides innovative and flexible technology for rapid and cost-effective approval of biosimilars to market. We provide innovation and speed to existing commercial models that reduce the time for pharma and biotech partners to manage their portfolios and development costs efficiently and effectively by bringing approved biosimilars to the process of licensing stages the market more rapidly. Our core strength is complemented by decades of experience working through the novelty of the regulatory path.