REGULATORY ASSESSMENT

bt_bb_section_bottom_section_coverage_image

Regulatory Assessment

It is imperative that an assessment of the regulatory journey of any product which is at the conceptualisation or early development stage should be mapped out with experts as early as possible. At AFR we have lost count of the cost (both financially and in terms of time and motivation) of the number of clients who first approached us at a point in a product’s evolution when key decisions had been made without any recourse to the regulatory landscape. Those uninformed decisions had not factored all relevant matters and were therefore the wrong ones, requiring significant retraction of work done, costs incurred and time lost.

The first stage of any new engagement at AFR is to go “back to basics” and make a root and branch assessment of the product and the manner in which it is manufactured, asking key questions at every touchpoint:

  • Is the likely to be a regulated product in X, Y or Z jurisdiction?
  • What are the chemical and botanical footprints of the ingredients and how do they manifest themselves in the end product?
  • Are there any inherent safety considerations within the product? Can they be mitigated? Have they been mitigated?
  • Are there any inherent safety considerations within the manufacturing process? Can they be mitigated? Have they been mitigated?
  • How will I gain regulatory approval for the product and protect the intellectual property within the product?
  • What are the likely costs and timeframes to market in differing jurisdictions?
  • How will I schedule the jurisdictional applications to ensure that the client commercialises the product in the swiftest time period?