ICH M7 Consulting

ICH M7 Consulting Service

Consulting Service

Douglas Connect & Leadscope
Providing European organisations outsourcing services and consulting in predictive toxicology to meet ICH M7 regulatory guidelines
ICH M7 Consulting Service Experience
Experience that makes a difference

The new ICH M7 guidance provides a specification for the use of in silico models for evaluating the genotoxicity of impurities in pharmaceuticals. The guidelines support the combined use of consensus models based on statistical-based (Q)SAR and expert rule-based computational toxicology combined with an expert opinion to support a regulatory submission.

Douglas Connect and Leadscope have established a partnership providing a market leading consulting service to execute the modelling and reporting requirements of such a regulatory submission.

The regulatory-accepted Leadscope software has been developed in close collaboration with the US FDA to satisfy the requirements for the ICH M7 guidance.

Douglas Connect scientists bring a depth of expertise in computational toxicology to execute all aspects of a client project. They have lead the creation of the OpenTox platform for validated (Q)SAR model building and regulatory reporting for REACH and the ToxBank infrastructure development.

Using their expertise and the Leadscope software, Douglas Connect can provide a complete outsourced solution to satisfy ICH M7 requirements.

ICH M7 Consulting Service Components
Evaluation of client requirements to support ICH M7
- Compliant (Q)SAR computational toxicology regulatory submissions
- Application of expert rule-based and statistical-based in silico models to generate results for client compounds
- Development of consensus models and rationale
- Provision of a chemical and biological interpretation of the results
- Preparation of an expert opinion for conflicting in silico results
- Provision of a detailed report to client containing results, analysis and expert opinion


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