The regulatory authorities of all three major regions (EMEA plus EU country authorities, FDA in the US and PMDA in Japan) have a great interest in pharmacogenomics.
They have all established a strategic framework, a dedicated group, and specific mechanisms for informal as well as formal discussions on pharmacogenomics.
PGXIS has forged links with the members of the regulatory authorities who are involved in the application of this technology to drug development, and can advise on the regulatory requirements and the most appropriate way to discuss potential studies or preliminary data with the authorities.


Strategic and portfolio advice
