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Competence Center:


In the highly regulated environments with constant change, such as life science, food, agriculture and forestry or, for example, security, it is absolutely necessary to strictly comply with laws and regulations. We sensitize and support our customers professionally in order to fulfill the necessary obligations promptly, for the safety of everyone involved.

This includes sectors such as life science, pharmaceutical, medical device and hospital care, chemical industry, food technology, agricultural and plant protection and occupational safety in general.

Other branches of industry, such as environmental technology, traffic and transport technology (road, rail, shipping and aviation), security technology & data protection, disposal and recycling management, as well as the energy industry, are also part of our portfolio.

Bild mit einer Glühbirne mit der Unterschrift Audit. Die Glühbirne ist erleuchtet und umgeben von den Worten Evaluation, Operations, Qualitiy, Procedure, Compliance und Assessment. Eine Hand hält einen weissen Kreidestift, bereit, mehr hinzuzufügen. Auditwesen. Audit.


Planning and implementation of audits with licensed, independent lead and co-auditors.
Individual audits according to ISO standard, e.g. 9001, 13485, 45001 etc., or according to GMP.
Assistance with official inspections or audits by Notified Bodies.
Analysis of the current situation with an audit report, according to ISO standard and GxP guidelines.

Training Webinar E-Learning Kompetenz Business Internet Technology Konzept. Training. Lernen. Verbessern.


​General internal and external compliance training and coaching in a wide variety of areas and industries.
Employee Qualifications
Training courses for internal auditors / co-auditors.

Roter Mann in der allgemeinen Struktur der Verbindungen der Menschen. Ein wichtiger Mitarbeiter. Ersetzbarer wertvoller Mitarbeiter. Fachmann und Fachmann. Erfahrung, Kommunikationsfähigkeiten.


​Support in resource management for specific key personnel:
Qualification area such as Responsible Person (RP) and Qualified Person (QP).
Task force management in the leadership area and in the organizational structure.
CAPA ("corrective action preventive action").
CIP ("continuous improvement process").

Konzept der Dokumentenmanagement-Datensystem Business-Internettechnologie. Dokumentation und Archivierung. Wie sichert man Daten? Datensicherung.

Documentation and archiving (data backup)

​Creation, implementation, training and maintenance of Standard Operational Procedures (SOPs).
Provision of templates for Site Master File (SMF), Validation Master Plan (VMP) and Corrective Action and Preventive Actions (CAPAs) etc.
Support in the processing and fulfillment of quality or safety-related specifications and documentation: such as CAPAs, Deviation Handling, Failure Mode and Effect Analysis (FMEA), Product Files and ISO 45001 etc.
Support for adequate and secure archiving systems.

Konzept der sozialen Verbindung. Bildliche Darstellung von Networking.

Networking (industrial organizations, universities, politics or authorities)

Overall coordination and interface management:

Exchange with research and development, trade associations, universities and technical colleges; contact with authorities.

Project mediation, support or mediation of bachelor's and master's theses.

Public Relations.

Sterile High Precision Manufacturing Laboratory, wo Wissenschaftler in der Schutzhülle schalten Maschinen, Computer und Mikroskope verwenden, Pharma-, Biotechnologie-Forschung. Investitionsprojekte und Transferleistungen.

Investment projects and transfer services

​Feasibility studies for projects at home and abroad (regulatory, technical, environmental, financial, etc.).
Redesigns, expansions, conversions of production sites and transfer lines at equipment or process level, as well as in the service and maintenance area.

Our Services


  • Planning and implementation of audits with licensed lead and co-auditors.

  • Assistance with official inspections or audits by Notified Bodies.

  • Analysis of the current situation with an audit report, according to ISO standard and GxP guidelines.


  • Determination of compliance and adherence to it.

  • Legal certainty, compliance with regulations, standards and laws.

  • Compliance with quality standards.

  • Risk assessments, risk management.

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