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Medical services (medical advisory projects, medical approvals of promotional materials and all type of scientific communication, regulatory and pharmacovigilance services) are in-sourced.

Our Medical Manager is the main liaison to The National Drug Agency and other regulating bodies in Romania). He is also responsible for submitting/renewal of MAs on behalf of MAH, implementing variances a/o.

As a pharmacovigilance officer, he is responsible for reporting and follow-up of SAEs, according to the current EMA/ Romanian legislation.

 


  • You want to expand your business on a market with a high potential
  • You want to prolong the life of your mature products
  • You can rely on professionals with expertise in the local pharmaceutical business, still young and enthusiastic
  • You need result-oriented people and we’re talking figures!
  • You can benefit from our entire range of services and stay in control without physically being here (basically, we can be your local “Representative Office” with lower costs)