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Consulting

Responsible Consulting is the result of many years' experience.
For a sophisticated process analysis we're using statistical design of experiments and variance analysis. This helps to reduce the number of experiments, trial- or validation-batches or to check on process robustness. Through our combination of process knowledge and process analysis, we can prevent errors in the process cycle thus saving you time and money on your project.

>  Risk analysis serves as method of choice in trouble-shooting and experiment design. On your road to a "risk-based approach" we will provide consulting on the individual implementation of the concept in your company.

Furthermore, we provide consulting in the field of medical products - covering the usage as pharmaceutical products as well. We will show you the interfaces of regulatory requirements and we will elaborate on a solution that will meet the demands of both medical and pharmaceutical products.

We also offer you our support for intra-company audits as preparation for official inspections as well as for     > PAI (Pre-Approval Inspection)
In addition, our service portfolio includes concepts for fire and explosion protection and likewise for clean rooms, monitoring or mock-up's.

We also offer > Inhouse-Seminars inter alia relating to:

  • statistical experiment design 
  • ISO 14644 
  • planning of containment-facilities 
  • pharmaceutical water system design 
  • medical products as pharmaceutical products 
  • GMP national vs. international