voisin consulting

Borderline Products

Voisin Consulting Life Sciences has developed solid expertise in the identification and justification of the regulatory framework(s) into which a borderline product may fall. Borderline products are at the border between drug, device, cosmetics and food, e.g. products for cosmetic surgery, food/cosmetics with health claims, herbal medicines, etc.

VCLS provides recommendations on the optimal regulatory strategies for borderline product development, particularly when regulations are rapidly evolving, when no specific guidelines apply and where grey areas still exist.

  • Identification of regulatory status and suitable regulatory frameworks as per markets targeted
  • Request for designation - product qualification to Authorities
  • Close collaboration with regulatory authorities to discuss applicable requirements to ensure the most efficient regulatory pathway selection
  • Review of label claims – adequacy with the chosen regulatory strategy
  • Gap Analysis of data requirements taking into account anticipated label claims and applicable regulatory requirements
  • Assistance with clinical trials to support claims
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