Evolving Pharma
Research & Development

Scientific innovation and advanced technology solutions for Pharma companies

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

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.

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




Pharmaceutical Data Analysis

Large data sets present an untapped opportunity to uncover insights and streamline operations within the pharmaceutical sector. Our Data analytics expertise can be a powerful tool for speeding up drug discovery process and reduce the cost and speed up clinical trials.

Whether it's identifying new markets for sales and marketing or streamlining compliance in a complex and dynamic environment, the use of big data analytics in pharma enriches the decision-making process.

We design custom data pipelines using open-source or custom tools, construct data-driven dashboard, and offer a comprehensive suite of services for modern data pipelines. This allows pharmaceutical companies to leverage their existing data towards more enhanced business outcomes.









 

 

TESTIMONIALS

 

 

Thanks to the exceptional in silico genotoxicity assessment provided Scialgo, we were able to ensure the safety of our pharmaceutical products. The comprehensive reports prepared by their team were instrumental in gaining regulatory approval, and we are highly satisfied with their expertise and dedication.

- A Mumbai based pharmaceutical company known for its diverse range of healthcare products. With a focus on innovation and quality.

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 regulatory approval. We highly recommend their expertise to anyone seeking genotoxicity assessments for impurities in their products.

- A Pharma Company, headquartered in Hyderabad, Renowned for its commitment to R & D

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. We are highly satisfied with their expertise and commitment to compliance.

- A Baroda based Pharma company recognized as a top player in the pharmaceutical sector.

 

 











Pune (INDIA)

Scialgo Solutions LLP

Our dedicated team is on stand-by to assist. Connect with us today.

Phone: +91 94037 68916
E-mail: contact@scialgo.com
Address: A8/16, Kumar Padmalaya, Aundh, Pune - 411007