Precision to the last detail

GXP Engaged Core Services

  • Evaluation, review, setting-up and implementing QM systems in client companies, including writing or support with writing SOPs
  • Independent full or partial QM or QA coverage of client companies who need additional resources in QM/QA
  • Definition of and/or execution of QM and auditing plans for clinical studies
  • Conduction of audits for clients, covering all areas of clinical studies
including ...
  • investigational sites
  • critical suppliers
and key activities such as ...
  • investigational site study management
  • clinical monitoring
  • safety management
  • regulatory affairs
  • data management
  • biometrics
  • laboratory analytics
  • product manufacturing
and essential documents such as ...
  • protocols
  • patient information
  • informed consent documents
  • documentation
  • trial master files
  • clinical study reports
  • Standard Operating Procedures

The QM team involved in execution of GXP Engaged Auditing Services contracts has provided this type of service for small, mid-size and large companies in the pharmaceutical, biotechnology, medical device and related industries, since 2003.
Please refer to the "Experience" section of this Web site.