Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS WINS TOPRA AWARD FOR INNOVATION VCLS in silico Team has been recognised for their significant contribution to the large scale adoption of in silico medicine. LEARN MORE PEOPLE-POWERED SOLUTIONS The market and regulatory landscape are constantly evolving. At VCLS, we thrive on innovation. Finding new ways of achieving our clients’ goals keeps us at the forefront of an ever-changing environment. Regulatory Strategy & Submissions Design and implementation of global regulatory strategies to ensure expedited product development and commercialization. Learn more Nonclinical & Clinical Development Develop a nonclinical and clinical development plan with the regulator's point of view for a successful healthtech product launch. Learn more Chemistry, Manufacturing & Controls (CMC) Integrated regulatory, scientific and technical solutions to ensure regulatory compliance, flexibility on the production capability. Learn more Clinical Trial Operations Partner your way, we are your single contact for all activities towards your clinical success. Clinical Trial Operations Access to Market Evidence-focused integrated access solutions at the nexus of clinical and regulatory experience. Learn more Vigilance From pre-market product safety to post-market surveillance and data analysis to meet your safety and compliance needs. Learn more ALL VCLS SOLUTIONS FOCUS ON Digital Health De-risk your digital health technology development by applying appropriate regulatory framework at early stage. Learn more Cell, Gene and Tissue Therapies Gene therapy, somatic or stem cell therapy and tissue engineering are at the cutting edge of translational research. Learn more Microbiome Products Microbiome health products – drugs or foods? Here are some key considerations such as health claim you wish to make, the target population, budget and development timelines in developing such products. Learn more OUR SOLUTIONS FOR EACH STAGE OF DEVELOPMENT Market and regulatory challenges vary at each stage of product development – when to interact with health authorities and payers? Is a pediatric development plan necessary? Are clinical trial results adequate for both regulatory approval and market access? We recognize the importance of strategic analysis and decision-making in drug and medical device development. Our tailored solutions are adapted to your product development stage and we proactively tackle the challenges being faced. DRUGS From the bench to the test in human. Pre-clinical 1 Assessing safety and determining a safe dosing range. Early-stage Clinical Development 2 Demonstrating efficacy, safety, and cost-effectiveness. Late-stage Clinical Development 3 Streamlining the entire submission process. Registration 4 Product life cycle management. Commercialization & Post-launch 5 GROW WITH US MEDICAL DEVICES Analyzing prototype and concept design. Concept & Feasibility 1 Evaluation of biocompatibility and safety. Analytical validation. Preclinical Development 2 Assessing safety and performance, and gathering data for registration and access to market. Clinical Development 3 Assembling and filing the application. Market Approval 4 Mitigating risk and remaining compliant. Commercialization & Post-Market 5 ADVANCE WITH US NEWS AND RESOURCES NEWS VCLS announces the acquisition of Quanta Medical Paris, June 1st, 2021 – Voisin Consulting Life Sciences (VCLS), a leading global HealthTech product development consultancy company, today announced… WEBINAR FDA Deep Dive into FDA’s Expedited Programs for Drug Development If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by… WEBINAR EMA Unlocking the EMA Meetings: the Process and How to Prepare Adequately Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it… PUBLICATION Market Access Advanced therapies in the EU: challenges with HTA and real-world evidence Market access aims to make a health technology not only available and affordable for every patient, but also profitable for… ALL RESOURCES CAREER AT VCLS VCLS helps biotech, pharma and med tech companies delivering innovative therapies to patients. We are passionate about what we do, we dare to be different and challenge the status quo, while focusing on our mission of being the global partner to expedite access of HealthTech products to regulated markets. 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