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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How to Optimize CMC for Successful Cultured Meat Product Development
Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore,…
Case study
Innovative Marketing Authorization Transfer Preserves Vital Patient Supply
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
Case study
How To Expedite Clinical Development Via Early Access Programs
If you are developing a drug for a rare disease in the European Union, you may qualify for an Early…
Case study
A Proactive and Reactive Team in Orphan Drug Development
Are you in need of a proactive and reactive team in orphan drug development? An orphan drug is a designation…
Case study
Key CMC Challenges for Innovative Healthcare Products
Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product…
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Early Asset Strategic Positioning Enhances Product Development Plan
A French based research company was looking for a proper guidance on positioning their main asset and estimate the market…
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Solid Strategic Development Plans Eliminates the Blocking Points for Live Biotherapeutic Product
A French biotech had developed a live biotherapeutic product to target obesity and metabolic disease but were hindered by blocking…
Case study
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…
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