Feasibility study

Feasibility, Data Gap Analysis and Preliminary risk assessment are strategic exercises aimed at understanding the chances of success for a registration project in balance with the cost and timeline necessary to undertake it. These 3 services offer an increasing level of precision.

Feasibility is a service where ENC compares your registration objective versus the Regulation requirement, existing opportunities and known threads. ENC will explore a series of questions determining whether the applicant’s project is feasible or not. For example.

• Is the product already authorised in another country ?
• Is there a similar GAP in the EFSA conclusions?
• Is there potential scientific and regulatory roadblocks that could undermine the project ?
  • Known threats due to the active substance or its metabolites?
  • Are there LMRs?
  • Are the required studies protected?
  • What are the molecules endpoints?
  • What is the classification of the molecule?
  • Are there any known restrictions?
  • What are the homologation status? 
  • Can the Substance be found in ground water?
  • Etc.

ENC will write a comprehensive report discussing the known factors influencing the project and concluding on the likelihood of success and cost estimate.

A feasibility dossier can be completed with a DGA or PRA to increase the level of detail with regard to the studies that need to be generated and the strategical options available to the applicant.