Automating FDA compliance and approval
Think TurboTax, but for FDA.
We’re building a software platform to handle the compliance aspects of running a drug or medical device company. Compliance is an ongoing activity for companies in this space, and annual costs per company range anywhere from $100K to $100M. Being deemed not compliant can be devastating, preventing a company from selling any new product for months and sometimes years.
In lieu of hiring costly consultants or employees to address this problem, customers provide our platform access to their data, and the platform outputs documentation in the manner that FDA and other regulatory agencies are looking for.
By using our software platform, customers will cut their annual regulatory costs by 50% (on average) and reduce the risk that their products will not get approved for sale.