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Our consulting services for pharmaceutical companies
As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical devices manufacturers.
With our industry-leading consultancy comprised of a broad portfolio, we optimize manufacturing processes by developing tailor-made solutions according to your individual needs and time requirements. Count on us – we act global and local to unleash the potential of your business, today and tomorrow.
Validation consultingLine-Optimization and Guided WorkflowsMES consulting MOM consultingDigital ConsultingTrack & Trace consultingSupply chain management consultingCMC Statistical ConsultingConsulting Packages
Validation consulting
Our computerized system validation (CSV) experts support you in complying with regulatory standards at national and international levels.
Minimizing business risks, stable manufacturing processes, and product safety are good reasons why the validation services from Körber are important for regulated companies in the pharmaceutical, biotechnology, and medical technology industry.
Validation for pharmaceuticals biotechnology
Our specialists in the life sciences area define validation processes for your company, taking into account the latest directives to identify possible compliance risks.
Validation for the medical devices industry
Machine qualification
Utilizing proven and tested processes for commissioning, qualification, and validation, our equipment and validation specialists expedite machine qualification and validate your equipment – and thus faster into production.
Line-Optimization and Guided Workflows
Optimize production and make best possible use of your machine data with our line optimization solution. Harmonized interface are part of it as well. Digitize the format change and line clearance process chains using our guided workflows based on modern augmented reality solutions. It’s completely paperless, including the GMP documentation that is required.
Manufacturing Execution System consulting
We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.
The vertical planning data of the company level and the horizontal machine data of the production level must be linked as part of digitization. These integration concepts are just one aspect of our MES solutions, about which our experts will comprehensively advise you.
Independent consulting and implementation for MES
We advise you independently. From the selection of the appropriate solution to its implementation, which can be done at one or multiple locations, through support for the ongoing operation of your MES.
Consulting and implementation for PAS-X MES
We support you in every phase of the Werum PAS-X MES implementation. Within this framework, we relieve you of many tasks that you previously had to carry out yourself. That will make your work much simpler.
Master batch record design and support for PAS-X MES
Manufacturing Operations Management consulting
Our experts for Manufacturing Operations Management (MOM) consulting pose the key questions in Business Process Management: “Who does what, when, how, and using what?” Our answers are always made to measure and have one objective — to develop on-schedule, on-budget, and high-quality solutions for your company.
What’s more, we also offer comprehensive and innovative solutions for your data management. Your processes are optimized in several ways by using flexible systems and allow operations to be more cost-effective.
Business Process Management
We analyze, define, and harmonize your business processes so you can unleash your full potential.
Data & analyses
Data integrity
The use of data ensures progress in the pharmaceutical, biotechnology, and medical products industry. Exact and complete data minimizes the risks to the safety of patients and your company. We support you according to your needs!
Software implementation
Digital Consulting
We guide you through any phase of your digital transformation: From evaluating your current digital maturity level with precise industry benchmarking to exploring quick wins with a huge ROI potential. And we will of course support you with ongoing strategic consulting services to implement the right components of Pharma 4.0.
Track & Trace consulting
Our experts provide you with knowledgeable advice during every phase of a Track & Trace project, starting with the initial analysis and definition of the requirements (e.g. serialization, aggregation), incorporating the selection of systems and vendors, and extending to implementation. Regardless of whether it’s a matter of complete and partial projects or narrowly defined individual tasks, we are prepared to deal with all project scenarios and take responsibility for providing professional, on-budget, and on-time services.
Supply chain management consulting
For us, supply chain management consulting means holistically analyzing the regulated industries in various project phases. The complete material flow is examined from receipt to dispatch of the finished goods and improved, e.g. by components such as an efficient Warehouse Management System (WMS). And these components must adapt rapidly and cost-effectively to new regulatory requirements and processes. We’ll be happy to advise you.
CMC Statistical Consulting
Would you like to know how to successfully validate your processes, achieve regulatory filing and further improve the quality of your products? Use our process knowledge and statistical toolbox to gain deeper insights into your processes.
Consulting Packages
Seamlessly integrate innovative solutions into your machinery, optimising production with our expert support. Build a solid foundation of efficiency, precision, and innovation. We're your partners in success.
About us
We are your contact when it has to do with pharmaceutical products. As a leading system supplier, we advise you on everything from development through manufacturing and inspection all the way to the packaging of your products.
Our Team
We have already established ourselves on the market in the area of consulting at the start of the 2000s. In the two decades since then, we have been a fixed part of the pharmaceutical and biotechnology industry. Our consultants are experts for questions related to production in the regulated industry, and they find perfectly fitting solutions for your requirements.
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