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…
VCLS supports life science companies and engages in communication with regulators and payers. We partner with Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products globally.
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.
Learn moreDevelop a nonclinical and clinical development plan with the regulator's point of view for a successful healthtech product launch.
Learn moreIntegrated regulatory, scientific and technical solutions to ensure regulatory compliance, flexibility on the production capability.
Learn morePartner your way, we are your single contact for all activities towards your clinical success.
Clinical Trial OperationsEvidence-focused integrated access solutions at the nexus of clinical and regulatory experience.
Learn moreFrom pre-market product safety to post-market surveillance and data analysis to meet your safety and compliance needs.
Learn moreDe-risk your digital health technology development by applying appropriate regulatory framework at early stage.
Learn moreGene therapy, somatic or stem cell therapy and tissue engineering are at the cutting edge of translational research.
Learn moreMicrobiome 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.
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…
INTERACT Meetings What: CDER is now also accepting INTERACT Meetings. Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT)…
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling…
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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