SOP Writing

Medialis Helps To Ensure The Compliance Documentation Is Correct, Guiding You In The SOP Process.

Design 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.

Example of SOP

HCP (Healthcare provider) / HCO (Healthcare organization) Engagement & Contracting
This document will detail the correct steps regarding approaching and contracting of new Healthcare Organisations and/or Healthcare Professionals within a chosen therapy area.

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