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Market Access & Regulatory

Regulatory, Policy and Market Access are key functions for a healthcare/pharmaceutical and/or medical devices company. Given the complexity
and the continuous changes of the Romanian environment, being prepared to anticipate and to react to upcoming changes is a critical factor for the success of any business. Totem is providing senior expertise in this area, supporting its customers throughout the access to market journey.

  • Business development: integrated market entry services for international healthcare companies looking to set up commercial presence in Romania (full range of services from regulatory to detailed SFE plan).
  • Public Affairs & Regulatory services:
    • Regular monitoring and update on the relevant political and economic developments. Customers briefings and reports on topics of relevance.
    • Regular monitoring and assessment of relevant legislative developments.
    • Support with issue identification and proposal of solution and action plan
    • Support with stakeholders mapping and engagement plan. Outreach and working together with medical community, authorities, media, civil society, business partners a.o. to provide an integrated solution
    • Support with organizing relevant meetings and documentation required
    • Strategic communications advice and support
    • Offering tailored support to specific customer’s projects, involving a PA and/or regulatory angle