Regulatory approval is a critical milestone in product time to market. Each year, 60% of all submissions in the US are significantly delayed due to poor communication with the FDA, delaying market approval and costing companies thousands of dollars a day.
Our teams in Israel, the US and EU have thorough knowledge of the requirements and processes used by the regulatory authorities around the world. Our experienced regulatory team understand the importance of ensuring high regulatory standards while doing so in a timely manner. We have executed successful submissions to the FDA, the EMA and to other national regulatory authorities
When submitting to regulatory authorities, companies are required to follow the CDISC (Clinical Data Interchange Consortium) standards for clinical data. SubmIT provides all services required to make sure your data conforms to regulatory requirements.
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