INCOBUS GMBH
OUR SERVICES
Our consulting offerings and services are designed to support you in the successful realisation of your business objectives and to ensure sustainable success.
OVERVIEW
Consultancy services
Compliance & digitalisation strategies
COUNSELLING SERVICE
We develop and implement compliance and digitalisation strategies, design the project structure and support you during implementation – with the aim of continuously improving your quality standards.
We are the right partner for you!
Selection of systems & system integrators
COUNSELLING SERVICE
We can help you select the right systems and system integrators to meet your unique business needs and long-term strategic goals.
We keep it all in perspective for you!
The first aid
kit
COUNSELLING SERVICE
Our PMI-PMP® professionals get troubled projects back on track. With in-depth knowledge of compliance, we develop strategies to quickly reduce backlogs and support their implementation.
We won’t let you down!
OVERVIEW
SERVICES
Compliance & digitalisation strategies
SERVICES
We offer customised solutions, always adapted to individual customer requirements and industry-specific standards, for process analysis and development, the creation of compliance concepts and the development of process and system rollout strategies.
- Process Analysis & Development: Development of BPML based on a process architecture (either bespoke or client-based).
- Development of compliance concepts: Design of the QMS framework including process development/optimisation and a lean, comprehensive documentation concept (manuals/standards > SOP > WI, validation/qualification documentation, etc.) taking into account relevant internal and external requirements (e.g. company standards, FDA, EMA guidelines, etc.); creation of qualification/training concepts, implementation of training courses.
- Development of process and system implementation concepts (e.g. eQMS, LIMS, SAP, MES, etc.): tailored to the customer’s requirements and the desired level of digitalisation.
Selection of systems & system integrators
SERVICES
We can help you with the selection and evaluation of systems and vendors – from market research and specification through to due diligence and the final decision, always with a structured and transparent approach.
- Request for Information (RfI): Conducting initial market research, RfI document, evaluation of supplier responses / benchmarks, supplier shortlist (LONG LIST), RfP schedule, supplier notification & NDA.
- Specification: Creation of a general process map (EPC / BPMN) & description of workflows.
- Request for Proposal (RfP): URS requirements catalogue (functional / non-functional), RfP questionnaire, RfP price matrix, evaluation matrix (weighting of questionnaire & prices), RfP publication (cover letter, Q&A workshops), RfP bid analysis.
- Due Diligence: Execution of supplier QMS audit for each shortlisted supplier, reference customer visit, detailed migration concept (workshop), recommendation of supplier(s), preparation of management presentation.
The first aid
kit
SERVICES
We can help you reorganise project teams, manage stakeholders and optimise project management practices – from agile methods to backlog reduction and continuous improvement.
- Reorganisation of project teams and stakeholder management: Analysis of team performance, training and support, definition of clear roles and responsibilities, stakeholder involvement and expectation management.
- Optimise project management practices: Revising the communication approach, introducing agile methods where possible.
- Reflect and learn: Carry out post-implementation analysis (PIA), identify and apply improvements.
- Backlog reduction: Design a backlog reduction strategy and lead/support implementation.
OUR
Expertise at a glance
Our company offers specialised services in the areas of quality assurance, process optimisation, digitalisation and compliance. We take a risk-based approach and use agile methods. With many years of experience, we support our clients in the following areas:
QUALITY MANAGEMENT
QMS Implementation & Optimisation, GxP Compliance & Audits, Quality Supervision, CSV, CSA.
OPERATION SERVICES
Process analysis and development (end-to-end approach) to improve efficiency.
QUALITY CONTROL
Monitoring and optimising laboratory processes to ensure product quality.
REGULATORY AFFAIRS
Advice on organising regulatory department processes.
CLINICAL RESEARCH / R&D
Optimising & managing R&D processes as well as supporting clinical trial processes.
BUSINESS
COACHING
A key component of our service portfolio is business coaching. With our expertise, we support managers and teams in developing leadership strategies, mastering change processes, and optimising organisational structures. We also enhance team performance, strengthen the feedback culture, and resolve conflicts professionally. Through targeted skills and team development, we help you achieve your goals efficiently and create a positive working environment.
