Toxicological Risk Assessment

Toxicological-Assessment-Cosmetics- Pharmaceuticals-Medical-Devices-Chemicals

  • Expertise in EU Reg No 1223/2009 and the Modernization of Cosmetics Regulation Act (MoCRA) of the United States

  • Preparation of Cosmetic Product Safety Reports (CPSRs)

  • Preparation and upgradation of toxicological write-ups for individual ingredients

  • Use of state-of-the-art methodologies and the latest scientific knowledge

  • Evaluation of potential risks associated with products, including exposure assessments and hazard identification

  • Partnership to ensure product safety and conformance with applicable regulations

  • Derive health-based exposure limits (PDE and OEL)

  • Toxicological evaluation of Impurities and Excipients

  • Facilitate toxicology study placement (CRO identification, study design and monitor)

  • Execution of nonclinical safety assessment strategies across various therapeutic areas

  • Preparation of preclinical documents for regulatory submission (IND/CTA)

  • Help derive the maximum recommended starting dose (MRSD)

Frequently Asked Questions

  • Toxicological risk assessment is a scientific process that evaluates the potential adverse or hazardous effects of a product, ingredient, or chemical substance on human health and the environment. It involves analyzing toxicity data on substances, exposure levels to the substances, and other factors to determine the likelihood and severity of harm.

  • Toxicological risk assessment is crucial in ensuring the safety of cosmetics, consumer products, chemicals, pharmaceuticals, and more. It helps to ensure the safety of the consumers and meet relevant regulatory requirements. The toxicological assessment also helps regulatory bodies, industries, and policymakers make informed decisions to protect public health, identify potential risks, and implement appropriate mitigation measures.

  • Toxicological risk assessment can benefit your company in multiple ways. By conducting thorough assessments, you can identify and mitigate potential health and environmental risks associated with your products or processes. This enhances your efforts in safeguarding consumers, ensuring compliance with pertinent regulations, protecting the company's reputation, and ultimately reducing legal and financial liabilities.

  • SCIPEX is a leading provider of toxicological risk assessment services. With a team of experienced toxicologists and regulatory experts, SCIPEX offers comprehensive support in conducting risk assessments, data interpretation, exposure modeling, and regulatory compliance. We help clients navigate complex toxicology issues and develop risk management and communication strategies.

  • If you are interested in toxicological risk assessment services from SCIPEX, you can visit our website at www.scipex.com and navigate to the Contact section. There, you will find information on how to contact SCIPEX and discuss your specific requirements. Our team will guide you through the process and provide tailored solutions to meet your needs.