3 pillars for regulatory success

23-Apr-2015

Regulatory is sometimes an afterthought only surfacing once the months of product development have been completed.

3 pillars for regulatory success

Regulatory is sometimes an afterthought only surfacing once the months of product development have been completed. However, the efficacy and saleability of your product should not be the only major factor in product development. Ask yourself this question? Can we afford the costly implications of non-compliance, litigation or a product recall? For most organisations the answer will be a resounding - “No”.

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However, looking across the regulatory landscape in the post implementation phase of the EU Cosmetics Regulation 1223/2009. It appears that some organisations are struggling with implementation and interpretation of the new cosmetics regulations. Perhaps one of the main stumbling blocks is that historically regulatory has been considered as something to overcome rather than collaborate with. Yet success depends on departments working more closely together with regulatory - this will ease the process and promote a better understanding of the importance of the regulations. A successful launch without regulatory angst is one that incorporates the following 3 pillars:

Marketing

  • Strategy
  • Target audience
  • Claims
  • Advertising
  • Sales
  • Launch Date

Regulatory

  • Regional Compliance
  • Ingredients check
  • PIF Cosmetic Product Safety Report
  • Responsible Person
  • Product Registration/Notification
  • Confirms if it’s cosmetic/drug/quasi drug/cosmeceutical/OTC Monograph
  • REACH
  • Claims
  • Classification Labelling and Packaging
  • Post marketing surveillance

R&D Strategy/Quality/Supply

  • Raw materials specification
  • Formulation development
  • Manufacturing
  • Interfacing with supply chain
  • Packaging specifications
  • Quality & Risk Management
  • Stability testing and shelf life
  • Claims support (incl. clinical/consumer trials)
  • GMP
  • Artwork

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