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Product Expertise
Understanding the science behind your product
Orphan drugs, biologics, or implantable devices present completely different challenges.
Our work is led by product specialists, experienced in bringing to the market the type of
product that our clients are developing.
The basic promise of personalized medicine is predicated in large part on the expanding availability of biomarker-based testing. A majority of companion diagnostics (CDx) are in vitro diagnostic tests providing essential information for the safe and effective use of a corresponding therapeutic product – CDx help predict whether a specific treatment is suitable or not for a given patient. CDx tests will identify responsive patient sub-populations to a specific drug or a range of medicinal products, or those likely to experience adverse drug effects. Read More

VCLS Solutions

Science-based, global product development strategy and planning

  • Position product and claims
  • Advise on Rx-CDx co-development plan
  • Co-assess medicinal products and diagnostic regulatory pathway
  • Develop roadmaps towards international market approvals
  • Advise on/conduct regulatory bodies strategic and product development meetings (EMA, FDA)
Tactical operations

  • Assist with risks analysis and risk management plan
  • Optimize protocols for Rx and CDx clinical evaluation
  • Review performance evaluation and CDx regulatory dossiers (EU, US)
  • Optimize quality and vigilance systems
  • Advise on co-labeling & advertising
  • Identification of the appropriate CDx developer