Pharmetheus offers hands-on analyses and strategic advice across all different phases, in order to support our clients in drug development decisions.
Our experienced consultants perform hands-on modeling and simulation as population PK and/or PKPD analyses, but also NCA analyses. We also have a data management team and medical writer collaborators. Further, we are happy to provide you with expert advice on modeling and simulation strategies as well as clin pharm strategies on an hourly basis.
At Pharmetheus, we have extensive experience in PK and PK/PD analysis to support your regulatory interactions across the product life cycle: pre-submission, during submission and in the post-authorization phase. Our way of working, with traceability and accountability from data management to report finalization, is well adapted to regulatory requirements. In fact, the structured way of reporting developed at Pharmetheus has rendered positive attention from regulatory agencies. In addition, we have former assessors of clinical pharmacology and pharmacometrics on staff that may aid in developing your regulatory strategy with respect to the clinical pharmacology package.