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Case Study
Modifying the formulation, API, and packaging processes of a global pharmaceutical leader by implementing a related, compliant, and analytics solution based on a PLM.
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Chetu delivered a unified PLM platform that centralized formulation, API, packaging, and regulatory workflows—automating change control, strengthening compliance, and improving visibility to accelerate product development and reduce operational errors.
A leading international pharmaceutical company like ours, known for producing a wide range of branded and generic medicines, relied on Chetu to modernize our complex product development process. With more than 600 products distributed globally, we were facing growing challenges in managing formulations, ingredient data, and packaging standards, all while ensuring compliance with stringent global health regulations.
Despite its size and reputation, the client's product development processes were fragmented, leading to:
R&D departments monitored formulas in spreadsheets and LIMS, lacking a central version control system. It is dangerous and costly to manually alter multiple systems for even minor process changes.
The API testing procedures, supplier information, and certificates were stored in separate repositories. The use of outdated API specifications resulted in delays in batch and quality control.
Label and carton artwork were handled manually by global packaging teams and were rarely updated with regional specifics. Each failure to comply costs them weeks of re-work and regulatory submissions.
Change requests were not directly connected to dossiers or filings- all audits had taken days of document collation, a compliance nightmare in a business where the ability to trace is a significant factor.
Our goal was to link all elements of the pharmaceutical lifecycle (from formulation to packaging through regulatory release) via one, tested PLM environment. We collaborated with the R&D, regulatory, and quality teams to map the current workflow, identify redundancies, and design a digital thread that provided traceability and compliance at all levels.
Working alongside the client, our team of experts designed and implemented a drug-grade Product Lifecycle Management (PLM) system, constructed with global drug formulation and packaging processes in mind, to turn its complex workflows into a cohesive, data-driven platform.
Working alongside the client, our team of experts designed and implemented a drug-grade Product Lifecycle Management (PLM) system, constructed with global drug.
All the formulations, excipients, and API specifications are now stored in a centralized version-controlled PLM repository. Every update will initiate an automated impact analysis to ensure that all associated formulations, BOMs, and dossiers remain up to date.
Digital artwork workflows replaced manual revisions. Regional teams can now review, approve, and archive packaging and label designs through automated version control and regulatory sign-offs, streamlining the process.
We built an end-to-end ECR/ECO workflow that connects our PLM system with SAP ERP. Once a change is approved, the Bill of Materials and production records update automatically—eliminating manual steps and minimizing the risk of errors.
Built to meet FDA 21 CFR Part 11, GxP, and ICH Q10 standards, the module ensures complete data integrity with e-signatures, audit trails, and submission-ready reports.
A Power BI-driven interface gives leadership a real-time view of launch readiness, supplier certifications, and change control cycles.
The new PLM platform now provides a single source of truth for formulation, API, and packaging data, transforming how teams collaborate, comply, and launch.
Unified Digital Thread: Connected formulation → packaging → market release.
Compliance Confidence: Reduced audit prep from 10 days to under 2.
Speed to Market: Accelerated product launches by up to 50%.
Reduced Risk: Improved traceability of ingredients, suppliers, and formulations.
Cost Savings: Minimized rework and non-compliance penalties.
Our experts at Chetu understood that the client’s biggest challenge went beyond just managing its current complex systems. Drawing on deep expertise in custom PLM development and regulatory-driven process automation, we helped bridge the gap between innovation and compliance by replacing manual workflows with digital governance. With this, the client gained speed, accuracy, and peace of mind — all within a secure, validated environment.
The implementation, aside from solving critical inefficiencies, laid the foundation for future scalability. The PLM platform now positions the organization for continuous evolution, with AI-based predictive quality tools, automated regulatory updates, and supply chain visibility dashboards driving the next steps in the client's digital transformation.
Let our Chetu experts help you digitize your R&D, regulatory, and packaging workflows with custom PLM solutions built for compliance and speed.
Let our Chetu experts help you digitize your R&D, regulatory, and packaging workflows with custom PLM solutions built for compliance and speed.
Drop us a line or give us a ring. We'd love to hear from you and would be happy to answer any questions.
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