Ensure Compliance with Expert Risk Evaluations
At Indivirtus Healthcare Services Pvt. Ltd., our Toxicological Assessment service delivers scientifically validated insights into the health and environmental risks of pharmaceutical compounds. Using LD50, NOAEL, mutagenicity data, and global databases like ECHA and TOXNET, we ensure regulatory compliance for SDS, product registrations, and compliance submissions.
Our services provide comprehensive evaluations of pharmaceutical compounds, including acute (LD50, LC50) and chronic (NOAEL) toxicity, mutagenicity, genotoxicity, and biodegradability, using ECHA and TOXNET data for regulatory compliance.
Toxicological assessments ensure product safety, environmental compliance, and regulatory adherence, supporting safe product registrations and minimizing risks for global market approvals.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led toxicological evaluations, providing robust data to support SDS preparation, regulatory submissions, and compliance with global standards.
At Indivirtus Healthcare Services, our Toxicological Assessment services are led by certified toxicologists and regulatory experts specializing in pharmaceutical safety. We evaluate acute (LD50, LC50) and chronic (NOAEL) toxicity, assess mutagenicity and genotoxicity, and analyze biodegradability using global databases like ECHA and TOXNET.
Our rigorous approach integrates data-driven insights with regulatory expertise, delivering comprehensive and compliant reports that support product registrations, SDS preparation, and audit readiness for global markets.
Compound-Specific Toxicological Summary Report: Detailed analysis of compound risks.
Toxicity Classification Using LD50, LC50, NOAEL: Comprehensive toxicity profiles.
Mutagenicity and Genotoxicity Evaluations: Assessments of genetic safety risks.
Biodegradability Profile: Environmental impact analysis of compounds.
ECHA and TOXNET Data References: Validated data sources for regulatory submissions.
Our Toxicological Assessment services align with stringent global standards, ensuring your compounds meet regulatory requirements for safety and environmental compliance. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and submission success.
Our Toxicological Assessment services are essential for pharmaceutical manufacturers preparing SDS and regulatory submissions. Ideal for product safety evaluations, environmental compliance, and global market approvals, our solutions support risk assessments and audit readiness. Key use cases include assessing new drug compounds, ensuring compliance for API manufacturing, and supporting environmental safety for production processes.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led toxicological assessments backed by certified toxicologists and regulatory experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, data-driven evaluations, driving regulatory success and product safety.
LD50 and NOAEL are critical indicators of a substance's toxicity. LD50 reflects the dose at which 50% of test animals die, while NOAEL helps establish safe exposure levels in humans.
We assess mutagenicity through validated test results such as the Ames test, chromosomal aberration assays, and micronucleus tests, using data from ECHA, TOXNET, or sponsor studies.
It helps determine the compound’s environmental impact, especially for wastewater discharge and environmental safety evaluations during regulatory submissions.
Yes, data from ECHA and TOXNET are widely accepted in SDS, REACH, and ICH submissions. Our experts ensure the data meets relevance and reliability criteria.
You need to share the compound’s CAS number, molecular structure, and any available toxicity data. We also require intended use and exposure scenarios.
Our services include evaluations of LD50, LC50, NOAEL, mutagenicity, genotoxicity, and biodegradability, using ECHA and TOXNET data, to support SDS and regulatory submissions.
Pharmaceutical manufacturers preparing SDS, product registrations, or compliance submissions for new compounds or APIs benefit from our tailored toxicological evaluations.
Our services align with REACH (EC No. 1907/2006), OECD Guidelines, CLP Regulation, ICH M7, and ICH Q3D, ensuring compliance with global safety and regulatory standards.
Clients receive a compound-specific toxicological summary report, toxicity classifications, mutagenicity and genotoxicity evaluations, biodegradability profiles, and ECHA/TOXNET data references.
Yes, our services are tailored to your specific compounds, regulatory requirements, and submission needs, ensuring practical and compliant toxicological evaluations.
We provide comprehensive toxicity data and regulatory references to support Safety Data Sheet (SDS) preparation and product registration submissions for global markets.