Toxicology Solutions
Toxicology Solutions Inc (TSI) is an independent consulting company dedicated to providing toxicology and DMPK services to the pharmaceutical industry. With over 50 years of combined experience among its scientists, TSI offers scientific and strategic consulting, including nonclinical toxicology, in silico toxicity predictions, and GLP pharmacokinetic/toxicokinetic reports. Since 2012, TSI has committed to high-quality service, flexibility, and transparency, supporting clients through various stages of drug development and regulatory interactions.
Industries
Nr. of Employees
small (1-50)
Toxicology Solutions
San Diego, California, United States, North America
Services
Consulting on ADME strategy, pharmacokinetic analysis, human dose and PK prediction, clinical PK analysis and reporting, GLP toxicokinetic analysis, regulatory submission writing, and due diligence assessments.
Computational toxicology evaluations compliant with ICH M7 using multiple rule- and statistical-based in silico tools, expert review of (Q)SAR outputs, and preparation of regulatory-quality computational reports for mutagenicity assessment of impurities and degradants.
Evaluation of N-nitrosamine drug-substance-related impurities using carcinogenic potency categorization approaches and QSAR-derived assessments to determine acceptable intake limits in line with regulatory guidance.
Support for IND-enabling and registrational toxicology studies including protocol development, study design, CRO selection, on-site monitoring, GLP and non-GLP study report review, and QC of documents across a broad range of study types (single dose, repeat dose, carcinogenicity, reproductive, phototoxicity, genetic toxicology, safety pharmacology).
Toxicological risk assessments for product contamination and impurities, determination of PDE/ADI values, occupational health categorizations, and preparation of toxicology content for safety data sheets.
Support for regulatory interactions and submission content including interpretation of regulatory correspondence, participation in meetings, and writing of safety pharmacology, pharmacokinetics, and toxicology sections for INDs, NDAs, CTD modules, investigator brochures, and special protocol assessments.
Consulting on ADME strategy, pharmacokinetic analysis, human dose and PK prediction, clinical PK analysis and reporting, GLP toxicokinetic analysis, regulatory submission writing, and due diligence assessments.
Computational toxicology evaluations compliant with ICH M7 using multiple rule- and statistical-based in silico tools, expert review of (Q)SAR outputs, and preparation of regulatory-quality computational reports for mutagenicity assessment of impurities and degradants.
Evaluation of N-nitrosamine drug-substance-related impurities using carcinogenic potency categorization approaches and QSAR-derived assessments to determine acceptable intake limits in line with regulatory guidance.
Support for IND-enabling and registrational toxicology studies including protocol development, study design, CRO selection, on-site monitoring, GLP and non-GLP study report review, and QC of documents across a broad range of study types (single dose, repeat dose, carcinogenicity, reproductive, phototoxicity, genetic toxicology, safety pharmacology).
Toxicological risk assessments for product contamination and impurities, determination of PDE/ADI values, occupational health categorizations, and preparation of toxicology content for safety data sheets.
Support for regulatory interactions and submission content including interpretation of regulatory correspondence, participation in meetings, and writing of safety pharmacology, pharmacokinetics, and toxicology sections for INDs, NDAs, CTD modules, investigator brochures, and special protocol assessments.
Expertise Areas
- Nonclinical toxicology program management
- Drug metabolism and pharmacokinetics (DMPK/PK)
- Computational toxicology and (Q)SAR analyses
- Regulatory toxicology and ICH M7 impurity assessment
Key Technologies
- In silico QSAR and (Q)SAR modeling for genotoxicity
- Rule-based and statistical predictive toxicology algorithms
- Carcinogenic potency categorization (CPCA) methods
- GLP toxicokinetic (PK/TK) analysis and reporting
News & Updates
Join us at Booth 100!
A recent publication on in silico toxicity predictions.
A clinical trial publication.
A pharmacokinetics and safety study.
Member of the American College of Toxicology since 1999
Active involvement and service in various committees and awards.
Co-developer of the Computational Toxicology Specialty Section of SOT
Contributed to the development of a new specialty section in the Society of Toxicology.
Join us at Booth 100!
A recent publication on in silico toxicity predictions.
A clinical trial publication.
A pharmacokinetics and safety study.
Member of the American College of Toxicology since 1999
Active involvement and service in various committees and awards.
Co-developer of the Computational Toxicology Specialty Section of SOT
Contributed to the development of a new specialty section in the Society of Toxicology.