Our in-house CTIS Sponsor Master Trainer, trained by the EMA and first-hand knowledge of the CTR implementation make us fully empowered to accompany you through the best implementation strategy of the EU CTR
The regulatory landscape is 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.
Design and implementation of global regulatory strategies to ensure expedited product development and commercialization.
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Develop a nonclinical and clinical development plan with the regulator's point of view for a successful healthtech product launch.
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Integrated regulatory, scientific and technical solutions to ensure regulatory compliance, flexibility on the production capability.
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Partner your way, we are your single contact for all activities towards your clinical success.
Clinical Trial Operations
Evidence-focused integrated access solutions at the nexus of clinical and regulatory experience.
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From pre-market product safety to post-market surveillance and data analysis to meet your safety and compliance needs.
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De-risk your digital health technology development by applying appropriate regulatory framework at early stage.
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Gene therapy, somatic or stem cell therapy and tissue engineering are at the cutting edge of translational research.
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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 moreRegulatory challenges vary at each stage of product development – when to interact with health authorities? 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.
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If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
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The Medical Device Coordination Group (MDCG) recently published a new guidance entitled “Guidance on Clinical Evaluation (MDR) / Performance Evaluation…
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Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it…
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Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to…
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.
64 Avenue Pierre Grenier
92100 Boulogne
France
Phone : +33 (0)1 41 31 83 00
Fax : +33 (0)1 41 31 83 09
