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