VeNaV Consulting provides scientific, project management and operational services within Translational Medicine, specializing in DMPK and Chemistry-Biology-Pharmacology interfaces.
Each project is unique. We support with the same enthusiasm a broad spectrum of clients across the globe: Pharma/Biotech, medical devices, in-vitro diagnostics, academic institutions, ONG.
Services offered, among others, are:
▪ DMPK project management: strategy planning, target assessment, hit/lead optimization & characterization, package preparation for entry into clinics, basic PK predictions (IVIVE, DDI, first-in-human dose), due diligence reviews, in/out-licensing activities.
▪ Drug Clinical support: PK oversight, contribution to clinical trial design.
▪ In-house/Outsourcing of DMPK/PD and Toxicology studies: design/evaluation/troubleshooting of in-vitro ADME studies, animal PK/Toxicokinetic/Pharmacodynamic, Pharmacology/Biocompatibility assessments, other Bioanalytical activities. Full outsourcing workflow to CROs following current GxP rules and guidelines (ICH, FDA, EMA).
▪ Scientific Writing: Filing of regulatory packages for drugs (IB/IND/IMPD) and Medical Devices (MDR), scientific publications, reports.
This is not a limited list, please contact us to get tailored support to your idea