Update of health risk assessment and Expert reports for an OTC veterinary product regulatory submission

Background

The client wished to market a prescription veterinary treatment for dogs as an over-the-counter (OTC) product and was required to submit an updated data dossier complete with expert toxicological assessment.

Client

A large European company developing insecticidal formulations for use as Veterinary or Biocidal Products.

Project goals

To upgrade and improve the overall quality of the safety dossier, including critical new information on the active ingredient and excipients, and to provide an expert opinion on the various toxicological endpoints and risk assessment conclusions described.

Approach

The client provided comments from the regulatory authority tasked with reviewing the earlier submission. Bibra assessed the quality of the toxicological information presented in the dossier before conducting literature searches to identify any new data pertinent to the assessment of the active ingredient and excipients. Bibra also provided expert opinions on the presented endpoint summaries and updated the risk assessment report to incorporate developments in the biocidal products guidance.

Project outcome

Bibra was able to upgrade the relevant aspects of the safety dossier, providing a set of high-quality reports for timely re-submission to the competent authority.

Bibra project team

Daniel Threlfall

James Hopkins

Pete Watts

 

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