It is mandatory for pharmaceutical companies respectively Marketing Authorisation Holder to assess compliance of affiliates, supplier, marketing- and distribution partner and other 3rd parties through audits - as legally required.  

Auditing service

  • CSO Pharma audits conformity and compliance of affiliates and supplier respectively contracted parties.

  • You detect and uncover possible sources of errors and can undertake counter measures in due course.

Corrective and preventive actions (CAPA)

  • After the audit we are naturally at your disposal for issuing corrective and preventive action plans.

  • We give comrehensive advice and make proposals for practical measures.

Audit management

  • We analyse your needs and necessity for audits considering related risks and provide you with a prospective audit plan. Using the risk based approach this is done efficiently and resource optimised.
  • This includes professional audit management, follow-up and mechanisms to allow oversight for stakeholders and regulatory responsible persons (QP).

Support of internal audits 

  • CSO Pharma supports you also with professional expertise and experience by performing internal audits on your behalf. 

Please feel free to contact us. We are looking forward to your enquiry.

Labelling QM

Professionelles und qualifiziertes Management der Labellingdokumente >>

GDP training

CSO Pharma provides professional training on Good Distribution Practice >>