Serviços Científicos
Specialized impurity management, structural elucidation, and process risk assessment services designed for global regulatory compliance.
Analítica e Estrutura
Para impurezas desconhecidas
Elucidação Estrutural
Comprehensive interpretation of spectroscopic data to determine the exact structure of unknown compounds.
Analytical Saiba mais
Isolamento de Impurezas
Isolation and purification of unknown impurities from drug substances to enable full characterization.
Purification Saiba mais
Revisão de Amostra de COA
Review our standard documentation and data integrity formats to ensure alignment with your quality needs.
Documentation Ver amostra
Avaliação de Segurança e Risco
Justificativa regulatória
Mutagenicidade (ICH M7)
In silico and expert review assessments for impurity mutagenic potential in compliance with ICH M7.
Toxicology Saiba mais
Investigação de Nitrosaminas
Root cause analysis and control strategy development specifically for nitrosamine risks.
Nitrosamines Saiba mais
Determinação de TD50
Calculation and justification of TD50 values to establish acceptable intake limits for novel nitrosamines.
Calculations Saiba mais
Processo e Controle
Estratégias de mitigação
Avaliação do Fator de Purga
Evaluate the capability of your manufacturing process to purge toxic impurities and justify control skipping.
Process Saiba mais
Relatório de Falha de Nitrosamina
Scientific reporting for cases where synthesis or confirmation of a theoretical nitrosamine fails.
Reporting Saiba mais
Deficiências na Aplicação CEP
Consulting on the top 10 common deficiencies to avoid delays in your Certification of Suitability.
Regulatory Saiba mais
Suporte Personalizado
Projetos sob medida
