Regulatory Affairs

Approaches need to be tailored to focus on strategic planning of the registration procedure until the elaboration of the marketing. The drug lifecycle has to be defined as soon as possible and the medicinal product has to be further enhanced to remain marketable. We ensure the maintenance of excellent relationships with national and international regulatory bodies. Skilled professionals at Mediconomics retain expertise both in the fields of registration of medicinal products and certification of medical devices.

Exploration of possibilities – Elaborate the strategy – Guidance of the product to marketability

We excel at:

  • Consulting
  • Realisation: all authorisation procedures
  • Documentation: eCTD/CTD 
  • Product lifecycle management: variations/renewals 
  • Readability user testing