PPT CONSULTING
OUR SERVICES IN THE AREA OF PPT CONSULTING
We offer competent consulting and support for complex questions and topics in the areas of project and routine tasks as well as GMP (Ready) Consulting.
Our experts have in-depth knowledge of all internationally established GMP regulations, regulatory requirements, and detailed insights into the processes of your industry. This comprehensive expertise enables us to offer qualified and high-quality consulting in all relevant areas of GMP, taking into account business aspects.
Project tasks
- Product and process development
- Product and process optimization with regard to efficiency
- Data management and systems
- Pharma 4.0 – Digital Twin and data management
- Product and process transfers both technical and regulatory
- Submission strategy consulting
- Consulting and support for site development concepts
- Optimization of maintenance phases and intervals
- Industrialization and process development of new processes incl. implementation
- Visual inspection and leak testing
- Sustainability in the field of pharmaceutical product development and production
Project management consulting
- From investment planning to consulting in the set-up and organization of investment projects
- Set-up and consulting in project tools such as Project Execution Plan / Cost Controlling & Scheduling / Responsibilities / Claim- & Change-Management
- Consulting and support in scheduling of complex projects considering all relevant GMP activities and especially implementation parallel to running production and coordination of all shutdown activities
- Preparation and execution of contract award activities / purchasing within the scope of investment projects
Routine tasks
- Consulting for the optimization of maintenance phases, maintenance processes and intra-logistics flow
- Performance analysis of existing productions as well as OEE recording
- Conceptual design and implementation of systems for recording KPIs
GMP-Consulting
- Planning and execution of mock audits
- Consulting for the implementation of regulatory requirements
- Consulting and implementation of Q-processes such as change control management
- Preparation and also moderation of workshops for risk analyses
GMP-Ready-Consulting
- Support in entering the GMP world – incl. setting up a GMP-compliant quality management system
- Design and implementation of qualification and validation processes
- Creation of document templates for qualification and validation
Your contact in the area of PROJECT TASKS AND PROCEKTMANAGEMENT-CONSULTING
Your contact in the area of ROUTINE TASKS
Your contact in the area of GMP-Consulting und GMP-Ready-Consulting
