December 09, 2021

Insight 4: Identifying data gaps for US and EU approval of new agricultural active substance

A global chemical products manufacturer needed specialist guidance on data development in order to bring a new fungicide active substance to market.

The company had conducted a preliminary data gap analysis (DGA) for the active substance and established that it had a favorable hazard profile. However, whilst it had the resources to undertake the preliminary assessment in-house, it needed specialist guidance on higher tiered and definitive data development. The company engaged TSG to inform it of the overall data anticipated to secure United States Environmental Protection Agency (US EPA) acceptance of the substance’s proposed food use, as well as active substance approval in the European Union (EU).

Read the full case study to learn more; and stay tuned for tomorrow’s insight!


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