SOP- and Quality
Management Systems

Goal-oriented and efficient support for setting-up, re-organizing or improvement of SOP- and Quality Management Systems is offered to clients of the pharmaceutical-, biotech- and CRO industry.

Services may include:

  • Development of SOP systems from scratch or on basis of existing documents. Adapted to company needs and in cooperation with client
  • SOP writing/support/review for all areas of clinical development for sponsors and CROs, e.g. related to sponsor oversight
  • Support in setting-up quality management systems including controlled documents, auditing, training and procedures related to computerized systems
  • Conduct of mock-inspections. Identification of compliance and efficiency gaps. Ensuring audit- and inspection readiness.