SOP writing
The quality documentation required for pharmacovigilance systems and activities is extensive and specified in Volume 9A of the Rules Governing Medicinal Products in the EU. PrimeVigilance has prepared templates for comprehensive suites of Standard Operating Procedures in relation to clinical trial and postmarketing pharmacovigilance and risk management. These can be adapted and customised for client use. Preparation of SOPs de novo can take many weeks and the availability of templates can result in significant cost savings.
SOP writing - documented and compliant
For more information contact PrimeVigilance today
PrimeVigilance
in conjunction with Elliot Brown Consulting and Ergomed