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