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Clinical Trials
Ask the Experts: EU CTR/CTIS: Adoption and Early Experience
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…
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 activities towards your clinical success.
Clinical Trial Operations
Access to Market
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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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 moreOur solutions for each stage of development
Regulatory 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.
Drugs
Medical Devices
Resources
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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…
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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…
blog
Clinical Trials
COVID-19 – THE LEARNINGS AND LONG-TERM IMPACT IN CLINICAL STUDY MANAGEMENT IN THE EU/UK
Introduction At the beginning of 2020, COVID-19 pandemic hit the whole world and led to unprecedented measures, including general lockdown…
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.
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
