Bridging your regulatory needs to pharma solutions

  • Regulatory affairs

    For companies in the healthcare and pharmaceutical sector
  • Pharmacovigilance

    Monitoring of your products’ safety profile as well as medical literature for identifying potential adverse reactions
  • Information

    Timely information on all new requirements and updates in medicinal products legislation and pharmacovigilance amendments
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Pricing and reimbursement services

Since both Romanian and Bulgarian pricing and reimbursement systems are based on external reference prices your submission should be carefully planned and possible pitfalls should be investigated prior to submission of documents.

We provide advice on price formation legislation as well as positive drug list submissions according
to local reimbursement requirements.

This service also includes translation of all related documentation according to the adopted template by the authorities.

Of course we will ensure timely communication with experts and administrative support at all levels until we obtain successful price and reimbursement status for your product.