C H E M S O R T I A

Data Generation

Generate Compliant Chemical Data to Fill Your Regulatory Gaps

When Chemical Registration Requires New Testing and Data Development

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.

Professional Study Management and Laboratory Coordination

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.

Comprehensive Data Generation Solutions


We provide end-to-end data generation solutions to meet your regulatory testing requirements:
  • Identifying data generation needs through comprehensive gap analysis and regulatory requirement assessment
  • Connecting clients with our curated network of qualified testing laboratories and CROs worldwide
  • Developing strategic study protocols and testing strategies aligned with regulatory guidelines
  • Managing study initiation processes, including laboratory selection and contract negotiations
  • Providing ongoing study monitoring and quality oversight throughout the testing phase
  • Coordinating multi-study programs for complex data generation requirements
  • Ensuring compliance with Good Laboratory Practice (GLP) standards and regulatory protocols
  • Managing study timelines, milestones, and deliverable schedules across multiple projects
  • Conducting technical review and quality assessment of study reports and raw data
  • Facilitating expert consultation for specialized testing requirements and methodology selection
  • Supporting higher tonnage band transitions with appropriate additional data generation
  • Integrating newly generated data into existing dossiers and registration packages

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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