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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Pharma Support Services

As a specialized service provider Pharma Support Services is created to find answers to your regulatory queries and help your pharma business achieve compliance with the local requirements on the Bulgarian and Romanian markets. Taking care of all aspects from dossier evaluation through regulatory approval to post authorisation support we are ready to provide our expert advice at every step you need it. Once on the market you take care of selling your product, we take care of its regulatory compliance and safety concerns.

What we offer

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.