Regulatory-Ready Genotoxicity Assessment
Aligned with ICH M7
Confidently assess genotoxic impurities with expert-reviewed, submission-ready reports trusted by pharmaceutical and chemical organizations.
Confidently assess genotoxic impurities with expert-reviewed, submission-ready reports trusted by pharmaceutical and chemical organizations.
Based in Pune, India, Scialgo Solutions LLP is a technology company focused on pharma research and development, we help pharmaceutical and chemical companies make clear, defensible decisions on genotoxic impurities. By combining advanced in silico prediction with expert toxicological review, we deliver ICH M7-aligned assessments that stand up to regulatory scrutiny.
Our core expertise includes AI-driven toxicology prediction, computational genotoxicity assessment, derivation of PDE/OEL and PDE/ADE limits, and pharmaceutical data analytics. Over the years, we have built strong and trusted partnerships with leading generic pharmaceutical companies worldwide.
At Scialgo, fulfilling our clients' needs is a top priority. Our tradition of excellence is reflected in the partnerships we maintain and the quality services we continually deliver.
Leveraging cutting-edge scientific research and advanced AI to provide high-quality services to Pharma worldwide.
In alignment with ICH M7 guidelines, we provide computational genotoxicity assessments using expert rule-based and statistics-based evaluations supported by literature review. Our SciTox program applies these methods to assess substances for genotoxicity, mutagenicity, and carcinogenicity, delivering results aligned with global regulatory standards.
We deliver scientifically robust PDE and OEL derivations based on toxicological data and regulatory guidance. Our assessments combine expert evaluation with literature evidence to define safe exposure limits, presented in clear, defensible reports.
We facilitate nitrosamine potency prediction in alignment with the Carcinogenic Potency Categorization Approach (CPCA) guidelines, expert toxicological evaluation. Our approach integrates mechanistic insights with available data to ensure scientifically sound and defensible potency categorization.
Identifying the genotoxic potential of drug candidates and also impurities, intermediates, etc in API development early and reliably is a crucial aspect of the drug discovery and development process. Our genotoxicity assessment program, SciTox, leverages a combination of expert rule-based and statistics-based evaluations for genotoxic mutagenicity and carcinogenicity, while rigorously following the latest ICH M7 guidelines.
Genotoxicity test reports play a pivotal role in satisfying regulatory compliance. Our comprehensive SciTox reports assure alignment with regulatory standards and further extend comprehensive, one year free support for any regulatory queries.
We periodically validate our Quantitative Structure-Activity Relationship (QSAR) models to ensure they are updated per REACH guidelines and aligning with OECD guidance. Additionally, we provide expert derivation of PDE/OEL (Permissible Daily Exposure /Occupation Exposure Limit) limits. Our comprehensive approach makes Scialgo Solutions LLP a trustworthy partner for computational toxicology software and in-silico genotoxicity assessment.
Nitrosamines are a major concern for pharmaceutical companies due to their status as potential carcinogens. Our Nitrosamine potency prediction, part of our SciTox module, uses the latest Carcinogenic Potency Categorization Approach (CPCA).
The SciTox module can predict potency using an automated CPCA approach, expediting regulatory submissions to EMA, US FDA, and Health Canada while reducing regulatory burden.
We provide detailed SciTox reports along with necessary justifications, ensuring compliance with standards of regulators US FDA, EMA, EDQM, ANVISA Brazil, Health Canada, Japan PMDA, WHO etc.. Expert review for each report.
Large data sets present an untapped opportunity to uncover insights and streamline operations within the pharmaceutical sector.
Speeding up drug discovery and reducing costs through AI toxicology prediction.
Design custom data pipelines using open-source or custom tools.
Streamlining compliance in a complex and dynamic regulatory environment.
Construct data-driven dashboards for enhanced business outcomes.
Thanks to the exceptional in silico genotoxicity assessment provided Scialgo, we were able to ensure the safety of our pharmaceutical products. The comprehensive reports were instrumental in gaining regulatory approval.
We are truly impressed by the precision and efficiency of Scialgo's computational genotoxicity assessment services. Their in-depth reports not only met but exceeded our expectations leading to swift approval.
Partnering with Scialgo has significantly improved our genotoxicity assessment process. Their computational reports rigorously followed ICH M7 regulatory guidelines, leading to a streamlined approval process.
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