CMC dossier and impurity control strategy support
Our team has extensive experience in developing and documenting phase-appropriate impurity control strategies for small molecule drug substances, ensuring compliance with global regulatory standards and ICH guidelines.
Furthermore, we specialise in authoring the drug substance sections of Module 3 regulatory dossiers, providing comprehensive support for clients' CMC submissions across all phases of development and commercialization.
These services are seamlessly integrated into our broader small molecule process research and development offerings.
Key aspects of Asymchem’s control strategy services
ICH M7 and nitrosamine risk assessments
Support development of target attributes for API
IPC and intermediate control strategy
Elemental Impurity Risk Assessments
Impurity identification and tracking of impurities throughout the process
API specification authoring
Establishing reference standards
RSM and Intermediate selection
Critical process controls and critical quality attributes control
