Audits

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.