AJ PCA offers compliance services in several of the areas in medical support. I take on shorter as well as longer assignments. 

Services in Marketing Compliance include (but are not limited to):

  • Advice and support on promotional and non-promotional materials as well as activities arranged for healthcare and general public
  • Review and approval of promotional and non-promotional materials 
  • Review and approval of activities
  • Support to ensure compliance with Efpia Disclosure Code i.e. transfer of value from the pharmaceutical industry to healthcare
  • Support in implementing and updating marketing compliance processes
  • Preparation of training materials and performance of training in marketing compliance 

 

Services in Quality include (but are not limited to):

  • Support in implementing and maintaining of GxP quality system
  • Support in implementing and updating of processes
  • SOP writing
  • Preparation of training materials and performance of training in quality
  • Coordinating preparation, conduct and follow up of audits / inspections
  • Deviations and CAPA documentation

 

Services in Good Distribution Practice (GDP) include (but are not limited to):

  • Support in implementing and updating GDP processes
  • SOP writing
  • Preparation of training material and performance of training in GDP
  • Performance of GDP self inspection
  • Support in preparation of GDP inspection

 

Other services include (but are not limited to):

  • Routine work in Regulatory Affairs, e.g. Product Information texts.
  • Routine work in Pharmacovigilance, e.g. handling of safety reports
  • Preparation of training material and performance of training in Pharmacovigilance
  • Quality control of PSP