Scientific Services
Specialized impurity management, structural elucidation, and process risk assessment services designed for global regulatory compliance.
Analytical & Structure
For unknown impurities
Structural Elucidation
Comprehensive interpretation of spectroscopic data to determine the exact structure of unknown compounds.
Analytical Learn more
Impurity Isolation
Isolation and purification of unknown impurities from drug substances to enable full characterization.
Purification Learn more
Sample COA Review
Review our standard documentation and data integrity formats to ensure alignment with your quality needs.
Documentation View sample
Safety & Risk Assessment
Regulatory justification
Mutagenicity (ICH M7)
In silico and expert review assessments for impurity mutagenic potential in compliance with ICH M7.
Toxicology Learn more
Nitrosamine Investigation
Root cause analysis and control strategy development specifically for nitrosamine risks.
Nitrosamines Learn more
TD50 Determination
Calculation and justification of TD50 values to establish acceptable intake limits for novel nitrosamines.
Calculations Learn more
Process & Control
Mitigation strategies
Purge Factor Assessment
Evaluate the capability of your manufacturing process to purge toxic impurities and justify control skipping.
Process Learn more
Nitrosamine Failure Report
Scientific reporting for cases where synthesis or confirmation of a theoretical nitrosamine fails.
Reporting Learn more
CEP Application Deficiencies
Consulting on the top 10 common deficiencies to avoid delays in your Certification of Suitability.
Regulatory Learn more
Custom Support
Tailored projects
