Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS ABOUT WHO WE ARE About WHO WE ARE Voisin Consulting Life Sciences (VCLS) is a team of more than 200 life sciences professionals, committed to delivering innovative therapies to patients. We believe that product development must be driven by a solid understanding of the environment within which the product will be launched, and the criteria by which elements of the development will be assessed by both regulators and payers. We start from science and medical needs, as we collaborate with our clients’ teams to drive innovative products along development and commercialization. From discovery to patients, our team of healthtech product specialists offers integrated solutions to development planning, manufacturing, quality and control, nonclinical and clinical testing, safety monitoring, and interactions with regulators and payers. OUR MISSION Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets. OUR VISION Science transforms lives, we successfully partner with innovative pharma biotech and device developers for the benefit of patients. OUR VALUES People We empower individuals and teams and provide them with an environment to grow and succeed. We treat others as we would like to be treated with trust, respect and fairness. We recognize effort and reward success. Innovation We dare to think out of the box and disrupt the status quo. We challenge everything in due time, we accept challenge and the right to fail. In an uncertain, ambiguous and complex world, we move and change with agility. Passion We work with energy and enthusiasm and we have fun. We take ownership of our tasks, projects and missions. We promote the synergy of teamwork. Excellence We consistently do our best to understand and satisfy the needs of our partners, clients and colleagues. We bring true added value, discerning the necessary from the superfluous. We strive to make tomorrow better than today by continuous improvement and learning. OUR STORY 1997 Dr. Emmanuelle Voisin founded VCLS to offer a tailored service for emerging biotech companies 2000 VCLS clients’ were among the first four to obtain ODD in Europe (2000 was the year when EU orphan regulation came into force) 2002 Among the first four to obtain MAA in orphan indication for which the ODD granted in 2000 2003 Launched Clinical Trial Operation service 2005 Expanded to the US market with an office in Cambridge, US 2007 First to obtain MAA under Accelerated Approval Program (AAP) 2008 Launched services for Medical Device 2009 First to obtain MAA in ATMP 2014 Won International Regulatory Excellence Awards from TOPRA 2017 Inauguration of VCLS innovation center – Neighborhood, dedicated to start-ups. 2019 Dr. Emmanuelle Voisin leads the In Silico Policy Working Group at Avicenna Alliance International Working Group 2019 Expanded its capabilities in Northern Europe with the acquisition of IWA Consulting 2020 Partnered with its spin-off iliomad to develop GDPR services and digital tools to help maintain the confidentiality of private health information while allowing for the exchange of data sets among various stakeholders. 2021 Acquisition of Quanta Medical, a privately-held company focusing on designing, implementing and reporting clinical studies with proprietary digital tools for the healthcare industry. Expansion to China with the appointment of Dr. Linsen Du as General Manager of VCLS China. TO INFINITY AND BEYOND Partner with innovative pharma biotech and device developers to expedite access of HealthTech products to regulated markets for the benefit of patients. ABOUT Who We Are What We Do Why VCLS Team News Events PRESENTATION Digital health Navigate the maze of MDR for Medical Device Software This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some… JOIN US Have more impact than you ever imagined. SEE OPEN POSITIONS ABOUT US What We Do We provide actionable recommendations at every stage of the development process, enabling… Why VCLS Regulators and payers are two of the most important external stakeholders affecting… Team Led by Dr. Emmanuelle M. 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