Manufacturing CMC Services
Accelerate Cycle Times by 40% with Connected CMC Data
By transforming fragmented process data into a connected, AI-ready foundation, Zifo’s experts eliminate CMC-related bottlenecks to safely and efficiently scale your manufacturing operations.
Driving Manufacturing Success Through Expert Guidance
Chemistry, Manufacturing, and Controls (CMC) is critical to therapy development, requiring the flawless collation of complex manufacturing, stability, and analytical data for global regulatory approval (FDA, EMA). Aggregating this fragmented data is a time-consuming challenge. Zifo combines scientific domain knowledge to reconfigure process, AI know-how, regulatory expertise, and technology partnerships to simplify data integration, ensure compliance, and remove impediments on large scale manufacturing.
7 of the Top 15 Global Biopharma Partners
World-leading biopharma companies trust Zifo to digitize, integrate, and streamline their complex CMC and manufacturing operations.
Improved Performance
Accelerating the transition from R&D to commercial manufacturing by utilizing centralized digital recipes, PLM strategies, and structured knowledge graphs.
Up to 50% Reduction in Execution Timelines
Achieved by eliminating manual data transcription across ERP, LIMS, and CDS, and implementing intelligent, automated Review-by-Exception (RbE) workflows.
>99% Elimination of Documentation Errors
Thousands of hours saved annually per site by deploying automated data validation and GenAI workflows to rapidly synthesize raw manufacturing data into compliant CMC regulatory filings.
Enabling Rapid Response and Informed Decision-Making
As science is increasingly dependent on computing power, it is imperative for science-focused organizations to ensure smooth application integration and maintenance. Also, it is important to reduce instances of system downtime while providing quick support to business users.
End-to-End Consulting
End-to-end CMC consulting to guide your product from development to commercialization.We support formulation, analytical strategy, regulatory documentation, GMP readiness, and manufacturing scale-up. Our practical, risk-based approach helps simplify complex CMC decisions.
Data aggregation for eCTD and AI
AI-enabled data aggregation for faster, cleaner eCTD submissions. We organize, structure, and validate regulatory data across documents, modules, and sources. Improve submission readiness, reduce manual effort, and enhance consistency.
CMC Data Aggregation & AI-Ready Harmonization
Aggregating manufacturing and analytical data across siloed systems (ERP, LIMS, CDS, QMS) is challenging. Zifo builds robust, scalable data architectures that centralize your CMC data. We ensure your data is FAIR (Findable, Accessible, Interoperable, Reusable), providing an audit-ready source of truth for submissions and building the foundational data layer required for advanced AI and machine learning initiatives.
Predictive Process Monitoring & Digital Twins
Move from reactive quality control to proactive manufacturing. By applying AI to your Critical Process Parameters (CPPs) and historical batch data, we help you build predictive models and digital twins. This empowers your teams to forecast yield, anticipate equipment maintenance, and continuously optimize manufacturing processes in real-time.
Gen AI for CMC Documentation
Drafting complex CMC sections for regulatory filings requires massive manual effort. Zifo leverages Gen AI and natural language processing (NLP) to rapidly synthesize manufacturing data, automate the drafting of standard compliance reports, and streamline regulatory documentation with high accuracy, freeing your scientists to focus on analysis.
Tech Transfer
Zifo offers handover of analytical testing processes, manufacturing process parameters, product specification data transfer, data integrity support, validation and compliance, and manufacturing plant design services. Successful tech transfer hinges on effective knowledge management amidst the rising tide of data.
Regulatory Compliance
From pre-clinical to commercial manufacturing, adhering to GxP and international guidelines is critical. We support the creation of rigorous digital frameworks for your CMC data, ensuring data integrity, traceability, and seamless preparation for electronic regulatory submissions.
Process Automation & Workflow Orchestration
Huge efficiency gains are possible by orchestrating workflows across your manufacturing environment. Zifo leverages both open-source and proprietary software, along with intelligent automation, to remove bottlenecks from the manufacturing lifecycle, driving resilient and cost-effective processes.
Manufacturing Batch Release Automation
We improve efficiency and scalability by optimizing, automating, validating, and controlling processes through BPMN, technology, and change management. Our solutions automate business rules and support data-driven decisions. Zifo integrates your ERP, LIMS, and CDS systems, automating business rules, and deploying AI-driven anomaly detection to deliver faster, highly scalable, and exceptionally accurate batch releases.
