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Follow up

The follow up is a service aiming to maintain communication with the authorities and manage the issues that may arise during or after evaluation. ENC’s consultants will evaluate the request of the authorities, communicate the conclusions to the client, provide them strategic advices and determine the feasibility on undertaking unexpected roadblocks.

What is a data call?

The authorities may request additional information, new studies, new risk assessment calculation with other endpoints, risk assessment refinement, etc. The applicant may have to answer to the authorities within a specified period of time in order to continue the registration process.

How to react to a data call?

Replying to a data call will balance the applicant’s means (study ownership, letter of access, budget, etc. ) with the authority’s level of requirement and the registration objectives. There are 3 main reactions to such comments.

Theses strategies involve different timeline, budget and chances of success.

The follow up may also be necessary after registration :

Thanks to its years of experience with Member States authorities, ENC understands the evaluator needs that lies behind the regulatory roadblocks.