Outsourcing of regulatory affairs tasks; why and what?


The outsourcing of regulatory affairs will continue according licentiate’s thesis by  Anu Gummerus, Oy Medfiles Ltd. According to the survey the value of outsourcing is the greater flexibility pharmaceutical companies obtain by outsourcing. In practice this means that a CRO can provide quick assistance in an urgent task once no own resources cannot be allocated. According to the survey, 70% of the respondents also outsource because  CROs have special knowledge and skills to provide. The most outsourced tasks were translations of the product information texts, readability testing of package leaflet and regulatory maintenance of the marketing authorizations. When a company is considering outsourcing the regulatory tasks, planning need to be done  carefully in advance. The main topics to be discussed between the company and CRO are the outsourcing strategy, ensuring information flow, cost estimation and audit trails.


  1. Outsourcing of regulatory affairs tasks in pharmaceutical companies – why and what? J Pharm Innov (2016): 11: 46-52
  2. Values and disadvantages of outsourcing the regulatory affairs tasks in pharmaceutical industry in EU countries. Pharmaceut Reg Affairs (2016): 5: 1

If you need practical view and advice concerning outsourcing of regulatory affairs tasks, please contact Anu Gummerus (anu.gummerus@medfiles.eu)

The latest posts in news & events

Let’s chat