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Required Regulatory 
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.
Basically, we 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"
Example of EMEA'S required sections where Predictive Medicine information has to be provided.
Investigation Medicinal Product Dossier (IMPD)
Primary pharmacodynamics
IMPD-2.2.1.2 Primary pharmacodynamics- Evidence to support the potential efficacy to the UMP in the proposed condition
Secondary pharmacodynamics
- IMPD-2.2.1.3 Secondary pharmacodynamics
Safety pharmacology
- IMPD-2.2.1.4 Safety pharmacology
Pharmacodynamics interactions
- IMPD-2.2.1.5 Pharmacodynamics interactions
Toxicological profile
- IMPD-2.2.3.2 Single Dose toxicity; 2.2.3.3 Repeated dose toxicity
Evaluation of mutagenicity
- IMPD-2.2.3.4.1 Genotoxicity Studies; in vitro studies
Anaxomics has helped Biopharma companies in their Regulatory relationships with EMEA and FDA
Learn more about Required RegulatoryPlease, contact us here to request more information.
