Pharmaceutical Toxicology
Comprehensive regulatory toxicology solutions for the pharmaceutical industry, from discovery to commercialisation.
Toxicological Services for the Pharmaceutical Industry
Specialised expertise with assessment and certification by European Registered Toxicologists (ERT)
REACH Monitor offers expert toxicology advice for the entire process within the pharmaceutical industry: from drug discovery to the commercialisation of the pharmaceutical product.
Our team includes European Registered Toxicologists (ERT), the highest certification standard in Europe, who can handle the most varied projects and prepare expert reports for any regulatory authority.
With over 25 years of experience, we provide comprehensive solutions to ensure your products comply with all applicable regulations, including ICH guidelines, enabling you to optimise resources and minimise risks in your pharmaceutical processes.
Our Regulatory Services
Specialised solutions for regulatory compliance and toxicological assessment in the pharmaceutical sector
Impurity and degradant qualification according to ICH guidelines
ICH Q3A(R2) — Impurities in new drug substances
Comprehensive evaluation of impurities in active substances, including identification, characterisation and establishment of safety limits in accordance with international standards.
ICH Q3B(R2) — Impurities in new drug products
Analysis and characterisation of degradation products and other impurities in final formulations, ensuring all requirements for product authorisation are met.
ICH Q3C(R6) — Guideline for residual solvents
Assessment of residual solvents according to their risk classification, establishing acceptable limits based on toxicity and risk to patients.
ICH M7(R1) — Assessment of DNA-reactive impurities
Analysis of potentially mutagenic and carcinogenic impurities, including assessment using computational methods (QSAR) and establishment of limits based on TTC methodologies.
Toxicological Assessment
Exhaustive analysis of the toxic potential of impurities based on structure, scientific literature and available experimental data.
Limit Calculation
Establishment of appropriate safety thresholds for impurities based on daily dose, treatment duration and specific toxicological characteristics.
QSAR Prediction
Application of QSAR models to predict mutagenic potential and other toxicological properties of impurities, reducing the need for experimental testing.
Permitted Daily Exposure (PDE) is a crucial parameter for ensuring safety in the manufacture of medicines in shared facilities. We provide comprehensive assessments to establish safe limits that minimise the risk of cross-contamination.
API PDE Assessment
Calculation of PDE values for active pharmaceutical ingredients according to EMA guidelines and other international regulations, enabling safe manufacture in shared facilities.
- Exhaustive review of toxicological data
- Selection of critical endpoints
- Application of appropriate adjustment factors
- Complete report with scientific justification
Cross-Contamination Risk Assessment
Complete analysis of cross-contamination risks in shared manufacturing processes, including determination of appropriate cleaning strategies.
- Cleaning acceptance limit calculation
- Product grouping strategies
- Trace evaluation in final products
- MACO (Maximum Allowable Carryover) level determination
PDE Expert Reports
Preparation of complete technical reports signed by European Registered Toxicologists (ERT), valid for submission to regulatory authorities.
- Compliance with EMA/CHMP/CVMP/SWP/169430/2012
- Detailed scientific justification
- Documentation for audits and inspections
- Support for resolving regulatory objections
Extractables and leachables from materials and components in contact with pharmaceutical products represent a critical area for product safety. Our comprehensive approach provides the scientific support to establish safe and appropriate limits.
Extractables Toxicological Profile
Detailed toxicological evaluation of extractable compounds identified in material characterisation studies, including packaging, medical devices and production systems.
- Exhaustive literature review
- Hazard characterisation
- Determination of toxicological reference points
- Exposure assessment by administration route
Safety Limit Establishment
Calculation of safety limits for potential leachables based on scientifically validated methodologies such as SCT (Safety Concern Threshold) or AET (Analytical Evaluation Threshold).
- Application of TTC methodologies as appropriate
- Determination of toxicity-based specific limits
- Consideration of special populations (paediatric, geriatric)
- Assessment of cumulative effects
Safety Expert Reports
Preparation of complete toxicological evaluation reports for extractables and leachables to support product registrations and respond to regulatory requirements.
- Documentation conforming to USP <1663> and <1664>
- Compliance with ISO 10993 guidelines where applicable
- Support for combination device assessments
- Review of analytical strategies for leachables studies
Safety Guidance
Expert advice for the development of toxicological evaluation programmes, selection of appropriate tests and monitoring of toxicological studies during pharmaceutical development.
- Design of tiered testing strategies
- Advice on in vitro and in vivo testing
- Evaluation of toxicological study results
- Interpretation of unexpected findings
Environmental Risk Assessment (ERA)
Complete assessment of the environmental impact of pharmaceutical products in accordance with EMA guidelines for marketing authorisation.
- Phased assessment strategies
- PEC (Predicted Environmental Concentration) determination
- Assessment of persistence, bioaccumulation and toxicity
- Development of mitigation measures where necessary
Toxicological Literature Review
Exhaustive bibliographic reviews to identify safety profiles, determine critical endpoints and support regulatory decisions.
- Systematic searches in scientific databases
- Critical evaluation of study quality
- Data synthesis for regulatory reports
- Identification of knowledge gaps
Our toxicology experts can prepare complete safety evaluation reports for new pharmaceutical entities, excipients, packaging materials and medical devices, meeting the highest international regulatory standards.
R&D Services in Pharmaceutical Toxicology
Innovative solutions to optimise the development and safety of pharmaceutical products
QSAR Prediction in Early Phases
- Toxicity screening within molecule libraries for candidate selection
- Preliminary evaluation of potential impurities, extractables and leachables
- ADME/Tox property prediction for early optimisation
- Reduction of animal testing through in silico strategies
Substance Substitution
- Identification of safer alternatives for problematic solvents
- Comparative evaluation of raw material toxicological profiles
- Optimisation of excipients and inert ingredients in formulations
- Strategies to minimise or eliminate CMR components
Our experienced team of toxicologists works closely with pharmaceutical R&D teams to integrate toxicological considerations from the earliest development phases, enabling early optimisation that reduces costs and development timelines.
Notable Examples
Success cases in toxicological consulting for the pharmaceutical sector