Making science workErfahren Sie wie

Making science work

Erfahren Sie wie


We have a close network of authority, industry and university representatives. From this pool of experts, we provide you a qualified mentor. We advise on the implementation of subject specific and interdisciplinary challenges in the ares of:

Quality Assurance

  • Establishment of quality management systems
  • Document management (SOP, specifications, master plans)
  • GMP training
  • Qualification of suppliers (packaging, active ingredients, technical service providers, installation construction)
  • Risk management
  • Cleaning validation
  • CAPA
  • Deviation management
  • Hygiene monitoring
  • Transport management and validation
  • Technical qualification of transport systems (active and passiv) transport simulation test
  • Preparation, monitoring and post-processing of audits


  • Process validation
  • Batch record review
  • Product quality report
  • Warehousing in according to GMP

Premises and Facilities

  • Supervision of renovations and new construction
  • Qualification functions (premises, facilities, equipment)
  • Technical building services
  • Maintenance and repair of premises, media and equipment

Quality Control

  • Sample measurement
  • Testing and evaluation of raw material and products
  • Equipment qualification and calibration
  • Validation of methods
  • Method transfer
  • Stability inspection
  • Preparation for GLP certification

Information Technology

  • Validation of computer-aided systemy (GAMP)


  • GMP basic training in the area of packaging: packaging and processes
  • Assessment and manufacture packaging

Management Techniques

  • Project management
  • Process analysis and optimisation
  • Trouble Shooting
  • Successful presentation
  • Effective structuring of meetings
  • Intercultural training

Further topics are available on request!

Dr. Martin Bornhöft
Telephone: ++49-6161 – 97 69 30

Dr. Katrin Kälkert
Telephone: ++49-6131 – 97 69 40