blog
Brexit
Key figures and dates of the Impact of Brexit for Pharmaceuticals
The current trading dynamic between the UK and EU, in the pharmaceutical sector, represents one of most integrated relationships of…
People-powered solutions
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.
Regulatory Strategy & Submissions
Design and implementation of global regulatory strategies to ensure expedited product development and commercialization.
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Nonclinical & Clinical Development
Develop a nonclinical and clinical development plan with the regulator's point of view for a successful healthtech product launch.
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Chemistry, Manufacturing & Controls (CMC)
Integrated regulatory, scientific and technical solutions to ensure regulatory compliance, flexibility on the production capability.
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Clinical Trial Operations
Partner your way, we are your single contact for all to your clinical success.
Clinical Trial Operations
Market Access
Evidence-focused integrated access solutions at the nexus of clinical and regulatory experience.
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Vigilance
From pre-market product safety to post-market surveillance and data analysis to meet your safety and compliance needs.
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Digital Health
De-risk your digital health technology development by applying appropriate regulatory framework at early stage.
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Cell, Gene and Tissue Therapies
Gene therapy, somatic or stem cell therapy and tissue engineering are at the cutting edge of translational research.
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COVID-19
We are closely monitoring the impact of COVID-19 on our industry and aim to bring you the very latest news from the Regulatory Agencies around the world.
Learn moreOur solutions for each stage of development
Regulatory challenges vary at each stage of product development – when to interact with healthcare authorities is a pediatric development plan necessary are clinical trial results adequate for both regulatory approval and market access etc.? 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 proactively tackle the challenges being faced.
Drugs
Medical Devices
Resources
blog
presentation
Medical Device
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…
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
EMA
An Advocate of Collaboration : Flora Giorgio Interview
Eric Wery, Vice President Market Access at VCLS conducted an Interview with Flora Georgio, Head of Sector HTA European Commission…
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 health tech products to regulated markets.
Get in touch
Paris, FR Office
64 Avenue Pierre Grenier
92100 Boulogne
France
Phone : +33 (0)1 41 31 83 00
Fax : +33 (0)1 41 31 83 09
