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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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…
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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…
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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…
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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…
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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…
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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…
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