The discussions will give an overview of the dynamic policy environments in US, France, Germany and provide answers to questions such as what digital products are eligible for reimbursement?
Feb 16, 2021 – 16:00 CET
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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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
