Comprehensive ICH-M7 assessments for starting materials, intermediates, and final API

Sai Life Sciences offers comprehensive ICH-M7 services to help assess the potential risks of our customers' starting materials, intermediates, and final API for mutagenicity assessment.

As mandated in the ICH M7 guidelines, pharmaceutical companies are now required to assess, identify, and categorize their starting materials, intermediates and final API routes of synthesis and resulting impurities to limit the potential mutagenic risks to patients.

Sai’s ICH-M7 services include:

• Comprehensive review of Routes Of Synthesis
• Insilico assessment of compounds using Knowledge (Derek Nexus, Lhasa) and Statistical (TOPKAT, BIOVIA) approaches to assess genotoxicity and carcinogenicity alerts
• Expert review and analysis to aid with decision making
• Documentation of GTI assessment with justification (as per ICH-M7 classification)
• In vitro and in vivo genotoxicity studies
• Comprehensive review of all data, and recommendations for next steps
• Support in identifying and implementing appropriate control strategies for mutagenic materials

Sai Life Sciences has handled over 100+ projects for its customers with their genotoxic impurity assessment and evaluation, helping them manage the risks associated with CMC regulatory concerns related to mutagenic risk.

To set up a meeting with our expert, email contact@sailife.com.