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