Körber Pharma Consulting Services

Körber Pharma offers specialized consultant teams that serve as personal partners for pharma companies.

These Körber consultants provide valuable advice and assistance to pharmaceutical, biotech, and medical devices manufacturers, helping them navigate the complex challenges of optimizing and digitalizing their processes in regulatory compliant environments.

Consultancy Portfolio

Körber’s broad consultancy portfolio encompasses a wide range of services offering tailored solutions to enhance manufacturing and distribution processes. These services include Validation Consulting, Manufacturing Operations Management, Digital Consulting, Track & Trace and supply chain solutions as well as CMC Statistical Consulting.

On top of that Körber and can also support pharmaceutical companies in optimizing their production lines and workflows, as well as in implementing MES Manufacturing Execution Systems such as PAS-X.

Validation & Qualification Consulting

Körber’s experts in computerized system validation (CSV) support pharmaceutical, biotechnology, and medtech companies in ensuring their IT systems align with regulatory standards at national and international levels to minimize business risks, ensure stable manufacturing processes, and product safety. These life sciences specialists define validation processes according to the latest directives, thereby identifying compliance risks.

Additionally, Körber’s machine qualification specialists employ proven processes, enabling faster and easier commissioning, qualification, and validation in order to shorten the time-to-production. This collaborative approach, made possible by Körber’s unique ecosystem synergies, leverages equipment and validation specialists to incorporate their technical and regulatory expertise at every stage of the project. Its qualification experts follow GxP principles and best practices defined by EU GMP Annex 15, ASTM E2500, ISPE Baseline Guide, etc. while the methodology adapts to the client framework and processes.

Manufacturing Operations Management consulting

Manufacturing Operations Management (MOM) consulting is all about addressing key questions in business process management, specifically regarding roles, processes, technologies, timing, and execution. This service is prioritizes delivering solutions that harmonize business processes and bolster data management to ensure on-schedule, on-budget and high-quality results.

Digital Consulting

Körber provides comprehensive guidance through all stages of digital transformation, starting from evaluating a client’s digital maturity level and industry benchmarks, all the way to facilitating a transition to Pharma 4.0 digital integration. Körber’s approach emphasizes gradual, value-driven components that deliver measurable ROI rather than pursuing radical, ambitious endeavors. The company leverages the BioPhorum industry framework and its Digital Plant Maturity Model to assess a company’s digital capabilities and maturity. This model identifies areas for improvement, including replacing paper-based documentation with Electronic Batch Records management.

Track & Trace consulting

Preventing the counterfeiting of pharmaceutical products is one of the most significant tasks facing pharmaceutical packaging companies. For this Körber offers solutions that enable product traceability, origin evidence, and pharmaceutical coding, while considering regional and national directives and GMP-compliant requirements. Körber’s intelligent Track & Trace solution enhances supply chain control and adaptability to evolving regulations. The company also assists with strategy implementation, offering expertise in compliant Track & Trace projects for global markets and providing validation services based on industry standards. Additionally, Körber can also offer a tailored solution for clients in the Asia-Pacific region, with efficient serialization services in local languages, as it is developed with a deep understanding of local requirements and is compliant with national verification systems.

Resources

Click on Körber Consulting Service for Pharma Companies for more information.