Case Studies
Projects from practice.
Selected engagements across the entire lifecycle. Anonymized for confidentiality, with the technical core that mattered.
Annex 1 Compliance in Sterile Manufacturing
An international pharmaceutical company specializing in sterile products had to align its processes and systems with the new requirements of Annex 1 of the EU GMP Guidelines.
International pharmaceutical company for sterile products
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Audit Software Integration for Improved Production Quality under GMP
An international software provider in the regulated life sciences environment needed a robust internal audit system to monitor production processes in line with GMP and reduce regulatory risk.
International software provider in the regulated life sciences environment
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Audit Support: Securing Reliable Audit Results
Provision of independent, experienced auditors to conduct audits to GMP and ISO standards, including report writing and CAPA follow-up.
Life sciences company with its own internal and external value chain
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Automated Syringe Inspection to Stabilise Capacity
Bottlenecks in manual syringe inspection and cold-chain risks threatened efficiency and product integrity in syringe production.
Pharmaceutical company with in-house syringe production
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AVI Implementation: 89 Manual Inspectors to 2 Machines
A sterile fill-finish facility ran 89 manual visual inspectors on a single production line. The question was not whether to automate, but how to validate the transition in a GMP environment without disrupting the inspection track record.
Sterile fill-finish manufacturer with large-scale GMP production
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Building a Supplier Management System with Continuous Monitoring
Building a risk-based supplier management system for a pharmaceutical company, including classification and qualification of suppliers.
Pharmaceutical company with a large number of suppliers and service providers subject to qualification requirements
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Conducting Mock Audits for Inspection Readiness
Preparing for a regulatory inspection through mock audits that put production processes, quality systems and documentation to the test in advance.
Pharmaceutical company with GMP-regulated production
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Cost Optimisation of Tablet Production
Tablet production was to become significantly more cost-efficient without jeopardising quality and compliance.
Pharmaceutical company with in-house tablet production
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Data Integrity and CSV to FDA Audit Standards
Outdated IT systems impaired data integrity and computer system validation and led to frequent data deviations.
Pharmaceutical company with an outdated IT landscape
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Data-Based Supply Chain Analysis with Power BI
Low transparency over bottlenecks in the supply chain led to inefficiencies and delays.
Pharmaceutical manufacturing company with a non-transparent supply chain
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Design Transfer of Combination Products from Development to Production
A medical device company with combination products needed to make the design transfer from development to production more efficient while overcoming regulatory hurdles under the EU MDR and the FDA.
A medical device company developing combination products
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Design-to-Scale-up: Processes for Scalable Growth
Insufficiently prepared business realisation processes held back growth and efficiency in the attempt to scale operations.
Medical technology manufacturer with ambitious growth targets
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Digital Demand Forecasting for Laboratory Consumables
A manufacturer of laboratory consumables needed better demand forecasting and greater transparency, because its data systems were not synchronized and a shared interface was missing.
A company that manufactures laboratory consumables and holds large volumes of critical data
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Digital Demand Forecasting for the Supply Chain Management of Healthcare Products
Delayed orders, short shelf lives and a lack of transparency made global demand planning difficult. A digital prototype was designed to improve demand management.
Global provider of healthcare products with a worldwide supply chain
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Digital Document Management Instead of a Paper Archive
The continued use of paper-based document storage caused inefficiencies and compliance risks.
Healthcare organisation with paper-based document storage
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Digitalising Manual Finance Processes
Heavily manual finance processes and outdated systems limited innovation and efficiency and raised operating costs.
Company with heavily manual, system-bound finance processes
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Fill-and-Finish Turnaround in Sterile Manufacturing
High downtime, recurring batch losses and staffing bottlenecks weighed on the fill-and-finish operation and lowered production efficiency.
Pharmaceutical company with an in-house fill-and-finish operation
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Greater Supply-Chain Transparency Through Data-Based Processes
Volatile planning and a lack of transparency over inventory led to inefficiencies and risks for the supply chain.
Pharmaceutical company with volatile demand and inventory planning
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Improving Overall Supply Chain Effectiveness at a Medical Device Manufacturer
Optimizing overall supply chain effectiveness at a medical device manufacturer, from demand planning and supplier management through to inventory control.
Medical device manufacturer with production- and procurement-side interfaces across the supply chain
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Integrating LIMS and ERP for Faster QA/QC Processes
Fragmented data exchange between LIMS and ERP forced manual data entry and caused delays in QA and QC.
Pharmaceutical company with separate LIMS and ERP systems
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Inventory Reduction and Process Optimization
High inventory levels, inaccurate forecasts, and an uncontrolled portfolio expansion were straining warehousing operations. Targeted measures were intended to reduce inventory and increase customer satisfaction.
Manufacturing company with a growing product portfolio, its own supply chain, and multiple production sites
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IT Support Backlog Cleared and GMP Lab Relocated
A considerable backlog in IT support and network administration impaired operations, affecting IT security and lab networking.
Healthcare company with a GMP-certified laboratory
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Lean Six Sigma in Sterile Filling and Packaging
Implementing Lean Six Sigma in the sterile filling and packaging operations of a pharmaceutical company, focused on cost reduction and a global lean program.
Pharmaceutical company with sterile filling and packaging at one manufacturing site
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OEE Optimization in the Production of Biochemical Active Ingredients
OEE optimization at a manufacturing site for biochemical active ingredients whose single production line had reached its capacity limits. The goal was to make downtime losses transparent and to make better use of available production capacity.
Manufacturing site for biochemical active ingredients with a single production line
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Operational Due Diligence for an M&A Integration
In the course of a merger, inconsistent compliance and limited standardisation shaped the operations of the newly combined organisation.
Life-sciences manufacturing company in the course of an acquisition
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Operational Excellence in Pharma Engineering
Step-by-step introduction of an operational excellence culture in pharma engineering, with a focus on change management, continuous improvement (CIP) and sustainable embedding in day-to-day operations.
Pharmaceutical company in pharma engineering
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Optimised Supplier Negotiations for Robust Savings
Savings achieved from supplier negotiations were perceived as insufficient by internal stakeholders.
Globally operating pharma manufacturer in procurement
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Optimising Cleaning Validation for Complex Product Lines
Unstable results in the cleaning validation of complex products led to inefficiencies and rising operating costs.
Pharmaceutical company with complex, multi-stage product lines
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Optimising Inbound Logistics at a Pharmaceutical Company
Undefined processes and unclear responsibilities led to delays and rising costs in inbound logistics.
Mid-sized pharmaceutical company with a growing supply chain
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Optimizing the Entire QC Laboratory Environment
Maturity assessment and optimization of the entire laboratory process landscape of a QC laboratory, from infrastructure and documentation through to workload management.
Pharmaceutical company with a quality control laboratory at the interface between production and research and development
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Project Cost Control Through Real-Time Dashboards
A missing overview of project status repeatedly led to delays and cost overruns; real-time data and automated tracking were lacking.
Pharma manufacturing company with project-driven production
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QC Lab Optimisation Through Clear Roles and Kanban Control
Insufficient prioritisation, unclear roles and low employee satisfaction led to bottlenecks and delays in the QC lab.
Pharmaceutical company with a heavily loaded QC lab
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Quality Control Transformation for Higher Productivity
Redundant management levels and non-value-adding activities kept quality control from reaching its productivity targets.
Biotech/pharmaceutical company with a heavily loaded quality control
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Quality Management for Process Stability and Compliance in a Pharmaceutical Production Line
A pharmaceutical manufacturer needed robust quality management processes for a new production line in order to close compliance gaps and secure on-time production.
A leading pharmaceutical manufacturer that needed to establish comprehensive quality management processes for a new production line to meet regulatory requirements. The identity of the client remains anonymous.
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Regulatory Affairs for Accelerated EU Software Approval in the Life Sciences Industry
A global software provider in the regulated life sciences environment needed a strategy to meet complex EU requirements without jeopardizing its product launch through lengthy processing times.
Global software provider in the regulated life sciences environment with multiple subsidiaries
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Regulatory Strategy for 510(k) Clearance and Successful US Market Entry
An international MedTech manufacturer was preparing to enter the US market on a fixed timeline and without experience of FDA requirements. Entourage developed the regulatory strategy for the 510(k) clearance.
An international MedTech manufacturer
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Restructuring the CDMO Network for Small-Batch Production
A CDMO setup unsuited to small-batch production threatened to cause supply delays and rising operating costs.
Pharmaceutical company with outsourced small-batch manufacturing
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SAP-Based Planning and Inventory Optimisation in Production
Fragmented supply and production planning led to inefficiencies, rising costs and suboptimal inventory levels.
Globally operating pharma manufacturer with an SAP landscape
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Seamless QP Coverage After a Short-Notice Absence
The short-notice absence of the internal Qualified Person threatened supply-chain continuity and regulatory compliance.
Pharmaceutical company with an internal Qualified Person
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Stabilising and Transferring a Tablet Production Line
Critical problems in the tablet production line led to budget escalation, production bottlenecks and frequent batch failures.
Pharmaceutical company with cross-site tablet production
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Supply and Production Planning Along the SAP Landscape
Inefficiencies and structural gaps in operations weighed on supply and production planning and drove up inventory and costs.
Pharmaceutical manufacturing company with an SAP system landscape
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Transparency and Control in the R&D Project Portfolio
Insufficient project management practices and a lack of transparency hampered decisions and resource allocation in the R&D portfolio.
Pharmaceutical company with a broad R&D project portfolio
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Transparent Financial Figures and Better Forecast Accuracy
Non-transparent financial figures and low forecast accuracy impaired strategic decisions and operational efficiency.
Medical technology organisation with low forecast accuracy
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Turnaround Management for Production Stability and Quality Optimization in Regulated Manufacturing Processes
Critical production disruptions called for swift, targeted action to stabilize operations and improve quality.
Mid-sized manufacturer of regulated products
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