Data Generation services address the critical need for new, additional, or upgraded datasets when existing information is insufficient to meet regulatory requirements under REACH-like regulations. Whether driven by data gaps identified during dossier review, tonnage band increases requiring higher-tier studies, or evolving regulatory demands for more comprehensive safety profiles, generating high-quality data is essential for successful chemical registration.
Regulatory testing requirements under REACH, KKDIK (Turkey), K-REACH (South Korea), and other global chemical management systems often necessitate specific study types that cannot be fulfilled through existing literature or database sources. Toxicological studies, ecotoxicological assessments, and physicochemical testing must meet stringent Good Laboratory Practice (GLP) standards while adhering to internationally recognized test guidelines such as OECD protocols.
Chemsortia connects registrants with our curated network of qualified testing laboratories and Contract Research Organizations (CROs), while providing comprehensive study management expertise throughout the entire process. From initial study design and protocol development to ongoing monitoring, quality oversight, and final report evaluation, we ensure that newly generated data meets the highest scientific and regulatory standards.
Our services encompass both scenarios where clients engage laboratories through our network and situations where they work with their preferred CROs while leveraging our technical expertise and project management capabilities. Effective data generation requires sophisticated coordination between regulatory requirements, study protocols, laboratory capabilities, and submission timelines across multiple jurisdictions.
The complexity of managing multi-study programs increases significantly when addressing higher tonnage band transitions or comprehensive data packages for multiple regulatory submissions. Professional study management ensures that all testing activities maintain consistency with regulatory expectations while optimizing resource allocation and timeline efficiency.
By combining strategic study planning with rigorous execution oversight, we deliver reliable, defensible data that strengthens registration dossiers and supports regulatory compliance across multiple jurisdictions.
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