SOP Writing
Medialis Helps To Ensure The Compliance Documentation Is Correct, Guiding You In The SOP Process.
scroll downDesign of global, EU affiliate and USA affiliate Medical Affairs Standard Operating Procedure (SOP) documentation.
Project Objectives
- Determine and agree on a list of core SOP documentation required for the newly created Medical Affairs departments working in the clients worldwide sites.
- Design, author and deliver the agreed list of SOP documentation
- Within the EU, SOP documentation will need to be duplicated and tailored for each applicable country, to ensure alignment with the correct local laws and regulations.
- In the first instance, EU documentation will be tailored for the UK, France, Germany, Italy, Spain, with a scope to expand the project to all ensure compliance with all EU member states.
