Support for the manufacturers of pharmaceuticals and biopharmaceuticals as well as pharmaceutical wholesalers

When it´s all about GxP

Interim management in the areas of

  • Management
  • Quality management
  • Head of production
  • Business development
  • Marketing & sales

Qualification/validation

  • Qualification of premises
  • Qualification of laboratory devices and production equipment
  • Validation of processes in the areas of production/cleaning/laboratories
  • Computer validation e.g. enterprise ressource planning systems (ERP) and process control systems
  • Implementation of measures to ensure compliance with the requirements for data integrity
  • Support in implementing the requirements for IT security according to ISO 27001

Pharmaceutical Quality System (PQS)

  • Preparing Product Quality Reviews (PQRs)
  • Conducting of mock audits or preparation and follow-up of audits
  • Preparing & accompanying of authority inspections
  • Supplier management, supplier qualification, auditing and preparing technical agreements
  • Deviation management incl. root cause analysis
  • Change processes/change management and CAPAs
  • Conducting gap analyses

Accompanying of technology and product transfers

  • Project management
  • Process validation
  • Selection of alternative manufacturers

Document management

  • Establishing, maintaining and further developing QM systems
  • Preparing and revising GMP documents such as Site Master Files, SOPs or manufacturing instructions
  • Introduction of document management systems

Training

  • Establishing training systems
  • Conducting staff training courses