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Required regulatory Predictive Medicine studies
In connection with regulatory requirements of EMEA and the FDA, Anaxomics provides ways to improve the consistency transparency and communication of benefit-risk assessments, through structured and qualitative approaches.
A Biotech Company engaget Anaxomics to write the corresponding chapters in their IND / IMPD submission regarding Predictive Medicine by using Safety Analysis embedded in the Therapeutic Performance Mapping Systems© service. Specifically, Anaxomics analysis was used to compile part of the 9A section: "Guidelines on Pharmacovigilance for Medicinal Products for Human Use".
Thanks to Anaxomics's support, the Company established solid relationships with regulatory agencies, paving the way for further approvals, and raising the threshold of innovation for direct competitors.
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