Life Science

Guaranteed no risks or side effects.

Whether pharmaceuticals, medical devices, cosmetics or dietary supplements: when it comes to sensitive manufacturing processes that are subject to the highest quality requirements, the know-how of our experts is indispensable. And that in two respects. Because we not only do we plan your plants and processes across all trades, we also certify them. This integrated approach increases efficiency right from the planning process – and at the same time ensures that GMP-regulated projects do not come with unpleasant surprises and delays.

No matter whether you need one of our services or want to entrust us with the complete planning, development and implementation process of your production plants: you can rely on our experience and dedication at all times.

GMP consulting

  • GMP audits
  • Gap analyses
  • GMP reviews of engineering concepts and planning documents of existing process plants and clean room technology
  • Review of hygiene concept
  • Feasibility studies for GMP upgrade of existing plants
  • GMP-compliant documentation, maintenance and calibration
  • Auditing of technical documentation, manufacturing and validation documentation

GMP engineering

  • Feasibility studies
  • Concept design
  • Basic + ext. Basic design
  • Detail design
  • Initial operation
  • Creation of requirement specifications
  • Supplier selection and support
  • Commissioning
  • Interface management

Qualification and validation

  • Creation of URS and requirement specifications
  • Creation of QMP/VMP
  • Creation of risk analyses
  • Creation and conducting of FAT/SAT
  • Creation and conducting of DQ/IQ/OQ/PQ

Training and workshops

  • Knowledge transfer of GMP principles
  • QA/QC (CAPA, change control, deviation management, audits), GMP-compliant documentation, maintenance and calibration
  • Risk analyses (FMEA, FTA, etc.)
  • Integrated engineering and qualification
  • Hygiene concepts in production
  • GMP-compliant documentation, maintenance and repairs
Life Science
Frankenthal Cologne
Dürkheimer Straße 130
D-67227 Frankenthal
Hubert Alter
Department Head Life Science
Phone +49 6233 6000-520
Frank Wischnewski
GMP Engineering
Phone +49 6233 6000-520
Markus Häberle
Qualification and Validation
Phone +49 6233 6000-520
Norbert Happ
Site Manager Cologne
Phone +49 221 1207169-0