Our team of experts has extensive experience in genotoxicity assessment. We ensure that your assessments align with regulatory requirements. SciTox streamlines the assessment process, saving you time and resources. Our experts review the report and add justification and recommendation wherever it is applicable. Many leading pharma companies rely on SciTox for genotoxicity assessment during DMF submissions.
Evolving Pharma
ABOUT US
Based in Pune, India, Scialgo Solutions LLP is a technology company focused on pharma research and development. Our devoted team brings a wealth of experience in collaboration with discovery research pharma companies.
We specialize in services such as computational genotoxicity assessment and pharmaceutical data analysis. Over the years, we've forged strong partnerships with renowned generic pharma companies around the globe.
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.
Why choose Scialgo
Experienced Team
Our experienced team that brings two decades of expertise in computer- aided drug discovery and predictive toxicity. With a deep understanding of cutting-edge technologies and a proven track record, we're committed to advancing pharmaceutical research and safety. Our team's extensive knowledge and dedication make us a valuable partner in your pursuit of innovation and safe drug development.
Our clients
Through our genotoxicity prediction services, we have forged strong partnerships with well- known generics Pharma companies, both within India and abroad, delivering reliable and regulatory-compliant assessments
OUR SERVICES
Leveraging cutting-site scientific research and advanced technology to provide high-quality services to Pharma companies worldwide.
in-silico Genotoxicity
In alignment with ICH M7 guidelines, we provide thorough computational genotoxicity analysis incorporating expert rule-based and statistics-based evaluations, along with an extensive literature review.
Nitrosamine Potency
We facilitate nitrosamine potency prediction in alignment with Carcinogenic Potency Categorization Approach (CPCA) guidelines and through judicious application of Read-Across (Rax) method and SAR.
Genotoxicity Assessment of Agrochemicals
SciTox, our genotoxicity assessment program, utilizes Expert Rule-based, Statistics-based evaluations, and literature reviews to evaluate agrochemicals and substances for genotoxic mutagenicity and carcinogenicity. It aligns with regulatory guidelines accepted by various bodies.
Data Analytics
We provide competent data analysis focused on accelerating drug discovery and development, enhancing clinical trial performance, driving efficient sales and marketing operations, and streamlining compliance.
Regulatory Toxicity
Computational Genotoxicity Assessment
Identifying the genotoxic potential of drug candidates 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. It will be rigorously abiding by the 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. Our comprehensive approach makes Scialgo Solutions LLP a trustworthy partner for in-silico genotoxicity assessment.
Nitrosamine Potency Prediction
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) and read-across methods.
The SciTox module can predict potency using an automated CPCA workflow, expediting the overall regulatory process. Our comprehensive reports ensure compliance with regulatory standards of EMA, US FDA, and Heath Canada.
Our expertise in this area delivers insights that assist in the rapid and informed decision-making process. This results in safer and more effective drugs for patients and a reduced regulatory burden for pharmaceutical companies.
Comprehensive Reporting
We provide detailed SciTox reports along with necessary justifications, ensuring compliance with standards of regulators US FDA, EMA, EDQM, ANVISA, US EPA, ECHA, Health Canada, Japan MOE, OECD, WHO. Expert review for each report
