EU Clinical Trial Regulation

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

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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 and submission

Regulatory Strategy & Submissions

Design and implementation of global regulatory strategies to ensure expedited product development and commercialization.

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Non clinical and clinical developement

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 Manufactoring and_Controls CMC

Chemistry, Manufacturing & Controls (CMC)

Integrated regulatory, scientific and technical solutions to ensure regulatory compliance, flexibility on the production capability.

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Clinical safety and operations

Clinical Trial Operations

Partner your way, we are your single contact for all activities towards your clinical success.

Clinical Trial Operations
Market access

Access to Market

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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Focus on

Mobile Health

Digital Health

De-risk your digital health technology development by applying appropriate regulatory framework at early stage.

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DNA molecules with binary code

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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The microbiome journey: development of a food product

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.

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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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Get in touch

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    Paris, FR Office

    64 Avenue Pierre Grenier
    92100 Boulogne

    Phone : +33 (0)1 41 31 83 00

    Fax : +33 (0)1 41 31 83 09