Pharmetheus offers consulting services focused on the application of quantitative approaches to support drug research, development and life-cycle decisions.
On September 30 and October 1, FDA and the Center for Research on Complex Generics (CRCG) will host a free virtual public workshop on Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches.
Pharmetheus’ Senior Consultant Erik Sjögren will contribute as a panelist at the panel discussion in the Symposium III/Session 4; "Model Acceptance and Model Sharing for Regulatory Use" on day 2, come and join!
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Our way of working, with traceability and accountability from data programming to report delivery, is well adapted to, and highly compatible with, current regulatory requirements.