Wissenschaftliche Dienstleistungen
Specialized impurity management, structural elucidation, and process risk assessment services designed for global regulatory compliance.
Analytik & Struktur
Für unbekannte Verunreinigungen
Strukturaufklärung
Comprehensive interpretation of spectroscopic data to determine the exact structure of unknown compounds.
Analytical Mehr erfahren
Isolierung von Verunreinigungen
Isolation and purification of unknown impurities from drug substances to enable full characterization.
Purification Mehr erfahren
COA-Musterprüfung
Review our standard documentation and data integrity formats to ensure alignment with your quality needs.
Documentation Muster ansehen
Sicherheits- & Risikobewertung
Regulatorische Begründung
Mutagenität (ICH M7)
In silico and expert review assessments for impurity mutagenic potential in compliance with ICH M7.
Toxicology Mehr erfahren
Nitrosamin-Untersuchung
Root cause analysis and control strategy development specifically for nitrosamine risks.
Nitrosamines Mehr erfahren
TD50-Bestimmung
Calculation and justification of TD50 values to establish acceptable intake limits for novel nitrosamines.
Calculations Mehr erfahren
Prozess & Kontrolle
Minderungsstrategien
Reinigungsfaktor-Bewertung
Evaluate the capability of your manufacturing process to purge toxic impurities and justify control skipping.
Process Mehr erfahren
Nitrosamin-Fehlerbericht
Scientific reporting for cases where synthesis or confirmation of a theoretical nitrosamine fails.
Reporting Mehr erfahren
Mängel bei CEP-Anträgen
Consulting on the top 10 common deficiencies to avoid delays in your Certification of Suitability.
Regulatory Mehr erfahren
Individueller Support
Maßgeschneiderte Projekte
