Voisin Consulting Life Sciences

Voisin Consulting Life Sciences is a services provider, CRO and consulting firm supporting drug, device, IVD and companion diagnostic development. Its portfolio spans market access, regulatory submissions, clinical operations and pharmacovigilance.

Regulatory Development & Submissions

• Planning regulatory pathways includes agency interactions, regulatory intelligence, IND and CTA support, marketing applications and lifecycle submissions.
• Preparing regulatory content covers IMPDs, Module 3 CMC sections, eCTD publishing and submission management.

Market Access & Evidence

• Developing access roadmaps, payer insights and reimbursement strategies uses stakeholder, standard-of-care, patient-journey and funding-route assessments.
• Building payer evidence packages includes literature reviews, indirect comparisons, network meta-analyses, economic models, value dossiers and HTA strategy.
• Handling local HTA, pricing and reimbursement processes includes negotiation guidance and anticipating access-policy changes.

Clinical Development & Safety

• Delivering clinical studies includes protocol design, site selection, recruitment, monitoring, data management, biostatistics, statistical analysis plans and clinical trial project management.
• Designing and executing early access programs is part of its late-stage support.
• Managing safety operations includes ICSR case processing from intake through regulatory submission, expedited reporting, signal evaluation, aggregate reports and risk management plans.
• Running pharmacovigilance systems covers safety system implementation, case exchange agreements with partners and affiliates, and PV audits and inspection readiness.

Devices, Diagnostics & Trial Tools

• Supporting device and diagnostic programs covers medical device and IVD regulatory affairs, IVDR compliance, companion diagnostic development strategy and post-market vigilance.
• Its clinical operations and data management work runs on Vision, its proprietary tools for data management, trial management, ePRO and eTMF.

Best Fit

• Best suited to sponsors needing coordinated regulatory, clinical, pharmacovigilance, market access or device and diagnostic development support.
• Relevant for teams seeking delivered clinical operations or managed safety work.