Cedience

Cedience is creating a software-based platform to help bio-pharma companies more reliably navigate the drug approval process, saving them meaningful time and expense.

More than 50% of drugs currently on the market have faced months – and, in many cases, years – of approval delays due to potentially unnecessary regulatory surprises and un-met regulatory requirements which could have been avoided. A core component of the regulatory approval process relies upon “precedent”, regulatory commentary, and information submitted or yielded from relevant trials in connection with other applications. Superior “regulatory intelligence” is a vital component for effective and efficient pursuit of drug approval; conversely, its absence is a massive and costly pain point. Cedience is bringing the power of modern technologies to provide new and effective tools to solve this problem. 

In the current environment, regulatory intelligence is generally the monitoring, gathering, and analyzing of publicly available and experience-based regulatory information needed to develop a strategy for time- and cost-saving drug development. Regulatory intelligence is not just information and knowledge management. There is a need to put the “intelligence” into the collected regulatory information by conducting an impact analysis and efficiently disseminating findings to build strategies. Regulatory intelligence can shape the environment to create competitive advantage.

Bringing new therapeutic products to market is a challenging process for many pharma/biotech and medical device companies, especially small/medium-sized ones. The breadth and organization of potentially relevant precedent, commentary, and trials is, by definition, not aligned with the pursuit of approval of specific novel therapeutics and compounds. The challenge is further exacerbated by differences in jurisdictional regulations, requirements, processes, and reporting. Small/medium organizations especially lack sufficient internal resources to meet the required local expertise. They especially need efficient and affordable guided insight on regulatory precedent. 

Emerging technologies and systems for monitoring regulatory requirements need to be implemented to address these challenges. The scale and complexity of the current regulatory environment has outpaced the ability of in-house teams of regulatory affairs professionals, which are typically small, to effectively manage compliance. Cedience’s technology is helping drug development teams conduct deep searches of the regulatory body of knowledge, identify unique regulatory precedents, properly prepare for regulatory interactions and submissions, and optimize their development strategies.