If your product must be submitted to the FDA, CDER or the European regulatory authorities, the challenges are complex and ongoing. The rules and requirements are constantly being updated. Time in getting your product to the consumer is the most valuable commodity you have.

Knowing the various stages of compliance and your investment in time is e-SubmissionsSolutions expertise.  To see the problems of the future and to work with you to find the answers means fewer delays.

Implementation of Regulatory Information Submission Standards (IRISS) (pronounced ‘Iris’ – the flower) is conceptualized to be a global, open, multidisciplinary, non-profit organization dedicated to the implementation and widespread, successful adoption of electronic regulatory submission standards around the world.