Tergus Pharma partnered with ERBrains to support its transformation from a Contract Research Organization (CRO) to a Contract Development and Manufacturing Organization (CDMO). By implementing Microsoft Dynamics 365 with process manufacturing capabilities, serialization, and 21 CFR Part 11 compliance, Tergus established a scalable digital foundation to manage project operations, manufacturing processes, regulatory requirements, and future growth initiatives.
Tergus Pharma is a leading end-to-end contract service provider specialising in topical pharmaceutical products. Operating from its state-of-the-art 100,000-square-foot facility in Durham, North Carolina, the organization supports formulation development, drug testing, clinical manufacturing, and commercial production for pharmaceutical companies worldwide.
Recognized for its expertise in topical semi-solids and liquid formulations across multiple routes of administration, Tergus continues to expand its capabilities while maintaining a strong focus on scientific excellence, quality, and regulatory compliance.
• Complex CRO-to-CDMO Transformation: Transitioning from a Contract Research Organization (CRO) to a Contract Development and Manufacturing Organization (CDMO) introduced significantly more complex operational requirements. • Need for an Integrated ERP Platform: The organization required a modern system capable of supporting both project-driven research activities and highly regulated pharmaceutical manufacturing operations. • Disconnected Manufacturing & Compliance Processes: Managing manufacturing workflows, product traceability, quality controls, and regulatory requirements across separate systems created operational inefficiencies. • Limited Scalability for Future Growth: Existing processes lacked the flexibility and scalability needed to support increasing production volumes, evolving customer requirements, and business expansion. • Stringent Regulatory Compliance Requirements: The organisation needed to comply with FDA 21 CFR Part 11 regulations while maintaining secure, auditable, and controlled business processes. • End-to-End Operational Visibility Challenges: Greater visibility was required across project management, manufacturing operations, inventory management, quality processes, and supply chain workflows.
• Pharmaceutical ERP Transformation: Implemented Microsoft Dynamics 365 ERP to support pharmaceutical development, manufacturing, and operational management within a unified platform. • Integrated Research & Manufacturing Operations: Connected project management, process manufacturing, inventory management, quality-focused workflows, and operational controls into a centralised environment. • Centralised Business Process Management: Enabled seamless management of research projects, product development activities, manufacturing operations, and supply chain processes through a single system. • 21 CFR Part 11 Compliance Enablement: Configured the platform to support electronic records, audit trails, process controls, and secure operational governance aligned with FDA regulatory requirements. • Enhanced Product Traceability: Implemented serialisation capabilities to strengthen product tracking, compliance readiness, and end-to-end manufacturing visibility. • Scalable Operational Framework: Established a connected platform that unified critical business functions while supporting future growth, operational expansion, and technology integrations. • Future-Ready Digital Foundation: Delivered a flexible ERP environment designed to support evolving business requirements, advanced manufacturing processes, and long-term pharmaceutical innovation.
The solution delivered pharmaceutical ERP capabilities, project management, process manufacturing, batch production management, serialization, inventory control, supply chain visibility, regulatory compliance management, electronic records support, audit tracking, operational reporting, and enterprise-wide process standardization.
Connected Pharmaceutical Operations Platform: Created a unified digital ecosystem that seamlessly connected pharmaceutical development and manufacturing operations within a highly regulated environment. Integrated Compliance & Manufacturing Workflows: Aligned business processes with industry compliance requirements while integrating project management, production planning, inventory management, and manufacturing operations. Built for Traceability & Regulatory Readiness: Implemented robust compliance controls, process traceability, and operational governance to support regulatory requirements and audit readiness. Scalable Foundation for Future Innovation: Designed the platform to support future business expansion, advanced manufacturing capabilities, and integration with additional enterprise systems and technologies.
• Microsoft Dynamics 365 ERP
• Process Manufacturing
• Project Management
• 21 CFR Part 11 Compliance
• Serialisation Management
• Batch Manufacturing
• Inventory Management
• Supply Chain Management
• Regulatory Compliance Controls
• Operational Reporting & Analytics
The new ERP platform provides Tergus Pharma with a future-ready foundation for continued growth and innovation. With integrated manufacturing operations, regulatory compliance capabilities, and scalable business processes, the organization is positioned to optimize production capacity, improve operational planning, and connect future systems such as LIMS, QMS, and R&D platforms within a unified digital ecosystem.
Successful CDMO Transformation: Established a modern ERP platform that supported Tergus Pharma's transition into a fully integrated Contract Development and Manufacturing Organization. Enhanced Manufacturing Control & Compliance: Improved manufacturing oversight, operational visibility, and regulatory compliance through standardized workflows and centralized data management. Strengthened Product Traceability: Implemented serialisation capabilities that enhanced traceability, regulatory readiness, and lifecycle visibility across manufacturing operations. Improved Planning & Operational Efficiency: Unified project management and manufacturing processes within a single platform, enabling better planning, streamlined operations, and increased productivity. Scalable Foundation for Future Innovation: Created a future-ready framework capable of supporting advanced manufacturing planning, digital transformation initiatives, and enterprise-wide operational optimization.
