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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You Will be in Great Company

Join the life sciences leaders using the ValGenesis Process Lifecycle Suite to remove barriers to innovation and accelerate delivery—by making process lifecycle execution consistent, connected, and efficient.

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corden pharma

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Customer Testimonials

corden pharma

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

gsk

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

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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

Integrating Digital Transformation and Quality by Design for Enhanced Pharmaceutical Development

Discover how digital platforms paired with QbD speed pharma development and support ICH compliance. ...

Industry Insight

Removing Bias from Risk Assessment

A data-driven, digital CMC development framework aligned that uses CPV evidence to reduce bias in ...

Industry Insight

Transforming Pharmaceutical Development: Combining Digital Platforms and QbD Principles

Cut paper bottlenecks with digital QbD workflows to speed risk assessments, reporting, and ...

Webinars

Reimagining Tech Transfers: How Automation and AI Assessments Deliver Smoother Processes

Tech transfer has always been a critical but challenging step in the pharma and biotech product ...

Revolutionizing CMC: Cutting Errors and Delays in Quality by Design

Quality by Design can transform how pharma organizations develop and manufacture products. But ...

Revolutionizing CMC in Drug Development: How to Reduce Errors and Delays in Quality by Design

Quality by Design in pharma offers significant potential—but many organizations struggle to ...

Videos

ValGenesis iCMC™: Science-Driven. Risk-Controlled. Designed for Robustness.

Replace scattered CMC docs with QbD-based, risk-controlled workflows in ValGenesis iCMC—watch now ...

Are You Still Doing QbD the Hard Way? The High Cost of Manual Data Entry

Cut manual QbD data entry in CMC. See how scattered data drives delays and errors—and how ...

The 3 Types of Quality Risk Management Tools and What They Do Best

Learn how identification, analysis, and evaluation tools support effective QRM. Understand how to ...

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.

From Molecule to Market. Faster.

Book a demo to see how ValGenesis iCMC™ can help you accelerate time to market.