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Resources

Case Studies

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

Post thumbnail Emergency Response: Getting Ahead of The Competitors
Post thumbnail Emergency Response: Getting Ahead of The Competitors Case study
FDA

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…

Post thumbnail Taking the Pain out of Clinical Studies for Medical Devices
Post thumbnail Taking the Pain out of Clinical Studies for Medical Devices Case study
Medical Device

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…

Post thumbnail An Integrated Regulatory and Market Access Solution for a Successful MAA
Post thumbnail An Integrated Regulatory and Market Access Solution for a Successful MAA Case study
EMA

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…

Post thumbnail Multidisciplinary Support for a Successful ODD Application
Post thumbnail Multidisciplinary Support for a Successful ODD Application Case study
Orphan & Rare Disease

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…

Post thumbnail Creating a Regulatory Strategy for Software as Medical Device
Post thumbnail Creating a Regulatory Strategy for Software as Medical Device Case study
Digital health

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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