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DirectoryBusiness & Technical ServicesOther Service IndustriesLausanneVoisin Consulting CH Sàrl
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Voisin Consulting CH Sàrl

Summary

About the company

Voisin Consulting CH Sàrl is a consultancy for HealthTech product development that provides regulatory strategy, clinical trial services, market access and vigilance. The company supports developers of biologics, medical devices, diagnostics and digital health products across stages from pre‑clinical through registration and post‑approval, including market entry into the US, EU and China.

AI-generated
Offering

Products & services

Industry:Other Service Industries
✓ Offered7
Regulatory
Regulatory strategy, global planning, agency interactions, dossier authoring, preparation, publishing, submissions and lifecycle management from strategy through post-market maintenance.
Clinical Trials
Clinical development strategy, clinical regulatory support, clinical operations, clinical safety and patient engagement across pre-clinical, early-stage and late-stage development.
Market Access
Landscape assessment, market access-inclusive development plans, evidence generation, health technology assessment and reimbursement, value communication and pricing support.
Vigilances
Pharmacovigilance and safety services including case management, safety regulatory support, signal detection, risk management, safety writing and post-marketing QPPV support.
Regulatory Consulting for the US Market
Regulatory strategy, FDA interactions, IND preparation, expedited program assessment, CMC planning, clinical safety systems and post-approval support for US market entry.
Regulatory Consulting for the European Market
Regulatory roadmap, EMA and national authority interactions, CTA and IMPD preparation, clinical and CMC planning, safety reporting and post-approval market access support in Europe.
Regulatory Consulting for the Chinese Market
Regulatory strategy, NMPA interactions, IND and marketing authorization support, dossier preparation, regulatory intelligence and cross-border collaboration for China.
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Location

EPFL
1015 Lausanne

At a glance

Legal form
Limited Liability Company
UID
CHE-112.162.667
Founded
2004 · 22 years
Last commercial register change
March 18, 2024
Employees
1 to 10

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