What do the new data requirements for EC 1107/2009 mean for your Agrochemical registrations?
Harlan Laboratories’ background data, set on virtually every active ingredient and over 30 years of experience working with hundreds of formulated products, gives you the advantage of getting your product to market with the lowest risk. Lean six sigma programs being undertaken at our sites allow our pricing to be more competitive than ever, without affecting our benchmark levels of quality.
Amongst other new requirements, authorities will now expect that submissions include:
- 5 year historical control data
- Increased genotoxicity data
- Increased in vitro assessments
- Requirement that all data is generated under GLP conditions
Our experts work in integrated teams across Regulatory, Toxicology (including Inhalation and Neurotoxicity), Environmental Fate, Environmental Toxicology, Analytical, Genetic Toxicology and Physico-Chemical Properties to ensure your project runs effortlessly.
Harlan is also one of the few CROs that can boast breadth and depth within the Agrochemical regulatory field. We are also unique in our dedicated Strategic Alliance Manager approach for all projects.
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