Toxicology Consulting Services
Elevate your regulatory journey with DDReg’s premier Toxicology Consulting Services. At DDReg, we deliver a comprehensive suite of toxicology and risk assessment solutions meticulously crafted to navigate the complexities of safety and compliance. Our team of expert Toxicologists and regulatory specialists is committed to optimizing your pre-clinical toxicity data, empowering your new product to advance into clinical testing at the desired dosage levels. We tailor our solutions to provide you with actionable insights and robust risk management strategies that are fully aligned with global regulatory standards, including ICH, ISO, GHS, and more. Trust DDReg to be your partner in achieving regulatory success.
DISCOVER MOREWhy Choose DDReg for Toxicology & Risk Assessment Services?
Our team of experienced toxicology consultants brings deep technical expertise in evaluating active pharmaceutical ingredients, excipients, impurities, and materials. By leveraging cutting‐edge methodologies, including in silico tools and risk assessments, we deliver innovative solutions that support global compliance. As a reputable toxicology consulting firm, we ensure that our strategies meet rigorous international guidelines.
With a focus on tailored toxicological strategies, we customize our solutions to address the unique challenges of each product and target demographic. Our experts provide actionable insights that align with global standards such as ICH, ISO, and GHS, ensuring your product’s safety and efficacy throughout its lifecycle.
Our Comprehensive Toxicological Solutions
At DDReg, we offer end-to-end toxicology services that cover the entire product development lifecycle. Our support spans from the assessment of Tox sections in IND applications to due diligence of toxicology data for clinical trial designs. We also provide expert advisory services to release clinical holds, ensuring that your risk management strategy is both robust and compliant.
Our solutions include everything from impurity qualification and benefit-risk assessments to in silico QSAR analysis for genotoxicity and nitrosamine risk evaluations. From supporting IND submissions for toxicology sections to reviewing generic products for their impurity profiles, we cover the entire toxicology value chain to ensure that your products meet safety standards and remain compliant to market requirements while on shelves.
Our Toxicology Expertise
- Assessment of Tox sections in IND applications
- Review and due diligence of toxicology data for Phase I & II clinical trials
- Toxicological justification and advisory to release clinical holds
- Benefit-risk assessment of active ingredients for various demographics
- Impurity qualification and SME support for impurity specification
- ICH M7 risk evaluation and impurity qualification framework
- In silico QSAR analysis for genotoxicity assessment
- Assessment of nitrosamine risks and establishment of acceptable intake levels
- Assessment and rationale for proposed limits on excipients
- Extractable and leachable risk assessment
- Biocompatibility assessment framework and study protocol development (ISO 10993 & ISO 18562)
- Toxicological evaluation of consumer products and ingredients
- GHS classification and Safety Data Sheet (SDS/MSDS) authoring
- Permitted daily exposure (PDE) and acceptable daily intake (ADE) evaluations
- Occupational exposure banding and limit assessments
- Environmental risk assessment for innovative products
Ready to elevate your regulatory toxicological journey?