GxP Advice

GxP Advice

The international legislation in GxP constantly changes. Thanks to advanced training programs our validation and compliance engineers have become experts in current regulations and directives. Agidens supports companies in the full preparation for audits and inspections by customers or by the government. For this we analyse your production processes and inspect your work instructions and Standard Operating Procedures (SOPs) to examine them against the most recent regulations.

We have a wealth of experience in the following sectors:
  • API production
  • Suppliers for the pharmaceutical industry
  • Pharmaceutical and biotechnological processes
  • Medical devices
  • Aseptic processes in hospitals, pharmacy and biotechnology

Rapid insight

Our broad experience in the pharmaceutical and biotechnological sectors ensures that within a few days you have a clear insight as to whether or not you comply with the current regulations.

Investigation is possible in the areas of:
  • General GMP (Good Manufacturing Practices)
  • Standard Operating Procedures (SOP)
  • Qualification and verification approach
  • Process validation
  • Thermal validation
  • Packaging and distribution
  • Logistics
  • Training
  • Computer System Validation (CSV)
  • HVAC and cleanrooms
  • Quality systems
We conclude such brief studies with a GxP Compliance Assessment Report. It contains a full overview of your activities, showing the measure to which you meet the guidelines and a list of recommendations for rectifying any shortcomings.

Contact a specialist

and get an answer within
three working days

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