科学サービス
Specialized impurity management, structural elucidation, and process risk assessment services designed for global regulatory compliance.
分析と構造
未知の不純物向け
構造解析
Comprehensive interpretation of spectroscopic data to determine the exact structure of unknown compounds.
Analytical 詳細を見る
不純物の単離
Isolation and purification of unknown impurities from drug substances to enable full characterization.
Purification 詳細を見る
COAサンプルレビュー
Review our standard documentation and data integrity formats to ensure alignment with your quality needs.
Documentation サンプルを見る
安全性およびリスク評価
規制上の正当性
変異原性 (ICH M7)
In silico and expert review assessments for impurity mutagenic potential in compliance with ICH M7.
Toxicology 詳細を見る
ニトロソアミン調査
Root cause analysis and control strategy development specifically for nitrosamine risks.
Nitrosamines 詳細を見る
TD50 決定
Calculation and justification of TD50 values to establish acceptable intake limits for novel nitrosamines.
Calculations 詳細を見る
プロセスと管理
リスク軽減戦略
パージファクター評価
Evaluate the capability of your manufacturing process to purge toxic impurities and justify control skipping.
Process 詳細を見る
ニトロソアミン不検出レポート
Scientific reporting for cases where synthesis or confirmation of a theoretical nitrosamine fails.
Reporting 詳細を見る
CEP申請の不備
Consulting on the top 10 common deficiencies to avoid delays in your Certification of Suitability.
Regulatory 詳細を見る
カスタムサポート
個別プロジェクト
