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DMPK Strategy & Project Representation
DMPK Strategy & Project Representation
Cross-Functional lead: DMPK/PD strategy and operational consultancy, bridging the interfaces of Chemistry, Biology, and Pharmacology within Translational Medicine.
Full-Cycle Project Support: Accompanying programs from Preclinical to Phase I/II: hit/lead optimization, target assessment, clinical candidate characterization, and early clinical PK support.
Versatile Pipeline Experience: Extensive foundation in small molecules (NCEs), with growing experience in mRNA and biologics (NBEs) across diverse therapeutic areas.
Full-Cycle Study Management & Basic Modeling
Full-Cycle Study Management & Basic Modeling
CRO Oversight: End-to-end workflow management under GxP guidelines for in vitro/in vivo ADME, animal PK/TK and PK/PD studies.
ADME Profiling: Absorption, binding & distribution, clearance, metabolism & transporters, and MetID.
Basic Modeling: Fit-for-purpose human PK and dose predictions, IVIVE, First-in-Human (FIH) dose estimation, and DDI risk assessments.
Regulatory &
Technical Writing
Regulatory &
Technical Writing
Global Filing Dossiers: Authoring/review of nonclinical DMPK sections for IB, IND/NDA, and other packages under GxP rules and guidelines (ICH, FDA, EMA, PMDA).
Technical & Study Documentation: responses to regulatory inquiries, SOPs, study plans/reports, technical summaries.
Targeted Support: regulatory writing for medical devices and IVD companies, scientific writing for academy and NGO institutions.
About VeNaV Consulting & Gloria
About VeNaV Consulting & Gloria
Hi, I'm Gloria Vendrell.
As an independent DMPK consultant with 10+ years of industrial R&D experience in Pharmaceutical Translational Medicine, I founded VeNaV Consulting to help biotech and life science organizations maximize asset value by providing critical expert input right when it is needed most.
My goal is simple: Providing the missing piece to achieve your project.
Core Approach
Flexible, Scalable Capacity: Light-touch strategic direction during routine screening phases, scaling smoothly to full engagement during IND package preparation or regulatory query responses.
Driven by Science & Quality: A passion for accurate, audit-ready deliverables grounded in technical rigor.
Transparent Partnership: Professionalism, enthusiasm, and transparent pricing built around your specific project milestones.
Let’s Discuss Your Project
Let’s Discuss Your Project
Whether you need immediate plug-and-play CRO oversight, strategic DMPK input, or assistance with upcoming regulatory filings, feel free to reach out directly.
Email: consulting@venav.org
Location: Switzerland (serving global clients across Europe, US, and APAC)
Response Time: Inquiries are typically answered within 24 business hours.
Engagement Terms: Flexible hourly or project-based rates tailored to your milestones. Reduced rates are available for non-profit organizations, academic institutions, and early-stage initiatives.
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