INCOBUS GMBH
Company
incobus stands for Innovation Consulting Business Services.
The incobus GmbH was founded in 2011 by Frank Wallrafen and is a consulting company specialising in the pharmaceutical, medical technology, food, and IT services sectors.
The company offers its high-quality and user-oriented consulting services worldwide.
At incobus GmbH, we have combined our skills, expertise, and passion to provide you, the client, with high-quality and specialised consulting services with the highest possible efficiency.
In addition, we offer business coaching to support managers and teams in strengthening leadership strategies, managing change, and optimising team performance.
Nothing works better
than sustained achievement!
WHAT characterises
incobus?
We keep the big picture in mind when planning and executing projects, enabling our clients to navigate the rapidly evolving life sciences and pharmaceutical landscape with confidence and achieve consistent success.
OUR MISSION
We help our clients succeed by providing tailored digitisation and compliance strategies, revitalising troubled projects and selecting the best systems and integrators.
OUR VISION
Through expert advice and strategic approaches, we aim to be a strong partner to the life sciences and pharmaceutical industries, enabling efficiency, innovation and compliance.
INCOBUS-TEAM
OUR CONSULTANT TEAM
Frank Wallrafen | CEO incobus GmbH
Expert in pharmaceuticals, food and IT
With over 20 years' experience in process and compliance management in the Life Sciences industry, Frank specialises in the development of quality strategies and modern, robust compliance frameworks, particularly in the area of digitalisation. As a GMP Lead Auditor, CSV and QA Manager, he has successfully led numerous projects in the areas of digitalisation, quality management and global process design. Frank's heart beats for complex digitisation projects. Thanks to his in-depth knowledge and level-headed approach, he is able to maintain an overview and put the right pieces together, even during turbulent project phases.
Specialisations:
- Analysis/evaluation and implementation of processes in the pharmaceutical, biotechnology, food, and medical device industries from a holistic perspective
- Consultancy in the establishment of a company-wide quality structure and support in harmonisation activities in the area of quality management systems
- Analysis and optimisation of workflows in the areas of quality, laboratory, regulatory affairs, and production with an end-to-end approach
- Lean digitalisation concepts (digital transformation) for GxP, clinical, laboratory, RA, R&D, and IT processes
- Coordination and support of complex system implementations in the highly regulated environment of quality management, laboratory, regulatory affairs, and production (e.g., eQMS, LIMS, RIMS, MES, etc.)
- Project management: design and support of organisational programme and project set-up, project management, stakeholder management
- Inspection/audit preparation; inspection readiness initiatives; mock audits
Academic background and expertise:
Chemical Engineer
Certified CSV Manager and QA Manager
GMP Auditor/Lead Auditor
- GxP Regulations: EU, FDA, WHO, ICH, PIC/S, IDMP, GAMP5
- Food regulations: FDA, IPEC, GFSI, IFS
- Systems: SAP (QM module, 21 Part 11 extension, SAP Solution Manager, archiving and BI reporting), LIMS (e.g., LabWare, MAQSIMA, …)
- Integrated overview
Languages: German, English, Dutch
Contact:
wallrafen@incobus.com
+49 171 5226772
Aachen, Germany
Kornelia Willms | Principal Consultant
Expert in pharma & quality management
Kornelia also brings over 20 years of experience in the pharmaceutical industry where she has held various roles such as QA Manager, Head of Sterility Assurance, Qualified Person (QP) and Laboratory Manager. Her background has given her a wide range of knowledge and experience in dealing with local and international authorities and their requirements (including FDA). She has worked both internally and externally as an auditor. Kornelia is an empathetic leader who can motivate teams with passion for even the driest compliance topics. She enjoys optimising work processes with a focus on sustainability.
Focus areas
- Analysis and optimisation of workflows in the areas of quality, laboratory, and production with an end-to-end approach
- Development, optimisation, and implementation of efficient processes in the quality management system (e.g., deviation, CAPA, change control, training and document management)
- Integration of quality risk management aspects in the GMP-regulated environment
- Development and implementation of concepts to improve quality monitoring (e.g., development of a quality KPI programme and KPI reporting)
- Development of strategies to reduce backlogs (backlog reduction)
- Development of training concepts for quality assurance, laboratory, and production personnel
- Delivery of training courses on all aspects of the QMS and the general quality culture
- Inspection/audit preparation; inspection readiness initiatives; mock audits
- Consultancy on topics related to aseptic production (e.g., implementation of Annex 1, establishment of CCS)
Academic background and expertise:
Qualified pharmacist
Responsible positions in the pharmaceutical industry
- GxP regulations: EU, FDA, WHO, ICH, PIC/S
Languages: German, English
Contact:
willms@incobus.com
+49 171 9119613
Frankfurt am Main, Germany
UNSER Experten-TEAM
Dr. Verena Pyrlik
Expert for laboratory and compliance at incobus GmbH (at the moment on parental leave)
Verena worked as a laboratory manager in the pharmaceutical industry for several years before joining incobus GmbH. Here she supports the team of consultants in the realisation of challenging projects in the pharmaceutical, IT and quality management sectors. Her main tasks are the creation and maintenance of project documentation as well as the planning, execution and evaluation of test cases. She works closely with our experienced consultants to ensure that all documentation and testing is carried out smoothly and efficiently. She is currently taking a sabbatical from incobus GmbH to focus on a family expansion project.
Alina Müller
Business Administration at incobus GmbH
Alina ensures that all administrative processes at incobus GmbH run smoothly. She is a great support to the team.
OUR
flexibility
To ensure the best results for our clients, we are able to deliver projects with the help of our own experts and additional trusted partners. This flexible approach allows us to tailor our team to the specific needs of each project and draw on a wide network of experts to deliver expert services and results.
POWERFUL PARTNER
