Every client is unique, every health tech product has its own characters, but some regulatory challenges are common during product development.
Learn how VCLS can provide you with tailored solutions to effectively move your product development forward.
Latest Case Studies
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Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage
A US based Biotech company was unaware of the EU’s requirement for a Pediatric Investigation Plan (PIP) until their product…
Case study
Emergency Response: Getting Ahead of The Competitors
A US based emerging biopharma recognized that one of their anti-viral therapeutics being developed for a different indication might also…
Case study
Taking the Pain out of Clinical Studies for Medical Devices
A French based research company were looking for guidance on developing a medical device to ensure MD safety validation. VCLS…
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An Integrated Regulatory and Market Access Solution for a Successful MAA
A US-based biotech looked for a trusted regulatory partner to: 1) Build and execute an EU regulatory strategy and roadmap…
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Multidisciplinary Support for a Successful ODD Application
A US biopharmaceutical client had to withdraw their ODD application during the COMP’s review procedure, due to the lack of…
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Creating a Regulatory Strategy for Software as Medical Device
A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring…
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