Occupational Safety and Cross-Contamination Risk Management

• Cleaning Validation: Thorough assessment of permitted daily exposure (PDE) and acceptable daily intake (ADE) levels for active pharmaceutical ingredients (APIs) and cleaning agents to establish robust cleaning validation protocols.
• Occupational Exposure Limits (OELs): Determination of safe occupational exposure limits for drug substances and intermediates, safeguarding workers’ health.
• Occupational Exposure Banding Categorization (OEB): Systematic categorization of drug substances and intermediates based on their toxicological properties to guide risk management strategies.

Toxicology Risk Assessments

• Impurities, Excipients, and Cleaning Agents: Rigorous evaluation of toxicological risks associated with impurities, excipients, and cleaning agents in pharmaceutical products.
• Extractables and Leachables: Assessment of potential risks from extractable and leachable substances from pharmaceutical packaging and medical devices.
• Threshold of Toxicological Concern (TTC): Establishment of scientifically sound safety thresholds using TTC assessments for impurities and other substances.
• Nitrosamine Risk Assessments: Specialized expertise in identifying and mitigating nitrosamine risks in pharmaceutical products.
• Expert Toxicological Statements: Preparation of expert toxicological statements for impurities to support regulatory submissions.
• Risk-Benefit Analysis: Comprehensive analysis of the risks and benefits of active pharmaceutical ingredients (APIs) to inform decision-making.
• Genotoxicity/Mutagenicity Assessment: In silico and in vitro assessment of genotoxic/mutagenic potential using QSAR tools (DEREK/SARAH/ICM7/OECD Toolbox/MULTICASE) and laboratory testing.
• ICH M7 Hazard Qualification: Application of ICH M7 guidelines for hazard qualification of impurities.
• MDD Reporting: Preparation of toxicology reports in compliance with Medical Device Directive (MDD) requirements.

Preclinical Toxicology Studies

• GLP and Non-GLP Studies: Design and execution of preclinical toxicology studies adhering to Good Laboratory Practice (GLP) guidelines or non-GLP exploratory studies.
• Efficacy Studies: Evaluation of the efficacy and safety of pharmaceutical compounds and medical devices.
• Genotoxicity/Mutagenicity Studies: In-depth assessment of genotoxic/mutagenic potential using in vitro and in vivo models.
• Biocompatibility Studies: Design and execution of biocompatibility studies for medical devices according to ISO 10993 and ISO 18562 standards.
• Biological Evaluation of Medical Devices: Assessment of the biological safety and compatibility of medical devices.