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Required regulatory Predictive Medicine studies
Business case 3
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 requested 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".
