Science-Driven.
Risk-Controlled.
Designed for Robustness.

ValGenesis iCMC™ enables quality by design in pharma with intelligent frameworks that drive robust processes, consistent product quality, and regulatory alignment.

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Empowering Life Sciences

We work with ValGenesis iCMC to digitalize our QbD framework within GSK for the development of new vaccines. We are confident that iCMC will be key for simplification, acceleration, and knowledge management.

Hervé Gressard

Head of Global Project Statistics CMC Technical R&D

When we decided to go with iCMC, we wanted to have the roll-out concluded within six months. The support we received from the team, their willingness to accommodate our requests and timelines, and their expertise in resolving all the issues that came up during the project was amazing.

Dr. Iris Ziegler

Director QbD & Pharmaceutical Sciences

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Discover How iCMC works as part of the ValGenesis Process Lifecycle Suite

iCMC centralizes process and analytical development—supporting QTPP definition, CQA and CPP analysis, and control strategy design in a collaborative, traceable environment. Teams can apply industry-standard risk assessment tools for pharmaceutical processes such as FMEA, PHA, HAZOP, and Ishikawa diagrams, with built-in guidance for regulatory alignment.

Advanced analytics, including predictive insights powered by machine learning, help teams identify trends, flag potential issues early, and optimize development strategies.

The platform supports digital validation planning, analytical method validation, project coordination, structured reporting, and knowledge reuse across products and facilities. With integration capabilities for QMS, MES, LIMS, and ERP, iCMC provides full lifecycle traceability—from early development to commercialization.

Overview

Download Product Sheet

Design robust, science-based processes

Apply QbD and risk-based principles to build quality into every stage of CMC in drug development.

Ensure consistency across products and sites

Unify process knowledge and reduce variability through standardized, traceable workflows.

Meet regulatory expectations with confidence

Align with global guidelines and maintain audit-ready documentation at every step.

Resources

Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Risk and Data as Knowledge Enablers: A ...

One of the goals of industry 4.0: to have an integrated end-to-end and ...

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Industry Insight

A Roadmap for Implementing Analytical QbD

A Roadmap for Implementing Analytical QbD

AQbD improves Analytical Target Profile robustness and makes drug ...

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Webinar

Data-Driven Risk Management: a Practical Approach to Minimize Subjectivity

Data-Driven Risk Management: a Practical ...

In this webinar, we will explain how ICH Q9 (R1) introduced the need to ...

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Industry Insight

Removing Bias from Risk Assessment

Removing Bias from Risk Assessment

In this Industry Insight we introduce you to an innovative framework that ...

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Webinar

Digital Transformation in CDMOs: Streamlining Tech Transfer Processes

Digital Transformation in CDMOs: ...

Tech Transfer processes are an integral part of (bio)pharmaceutical ...

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Industry Insight

Digital Transformation in CDMOs: Streamlining Tech Transfer Processes

Digital Transformation in CDMOs: ...

In the fast-paced world of pharmaceutical manufacturing, the power of ...

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Webinar

The Toolbox for an Effective Tech Transfer

The Toolbox for an Effective Tech Transfer

The implementation of digital tools in (bio)pharmaceutical Technology ...

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Webinar

A Roadmap to Digitalize Your Control Strategy

A Roadmap to Digitalize Your Control Strategy

Transforming traditional control strategies into digital frameworks is ...

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Frequently Asked Questions

Yes, iCMC can be applied during development phases to assess formulation, process parameters, critical quality attributes (CQAs), and potential failure modes. This supports science- and risk-based decision-making consistent with QbD principles.

Yes. iCMC can document and analyze the relationship between CQAs and CPPs, enabling better understanding of process control strategies and contributing to control strategy design.

Yes. iCMC can be used to assess process knowledge gaps, equipment risks, and environmental factors during site or technology transfers, helping ensure a seamless and risk-informed handoff.

Yes, iCMC facilitates QbD by enabling structured analysis of product and process knowledge, linking design space decisions with risk rationales, and supporting lifecycle risk management.