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

Medical device notification services

We provide comprehensive local advice, preparation and submission of medical device notifications.
Should you wish to apply for reimbursement of your medical device and if it is subject to reimbursement we will prepare and submit the necessary documents for obtaining reimbursement status as well.

As part of this service we also prepare translation and adaptation of your labeling and leaflet text so that it complies with the latest requirements. Of course we can also evaluate your text and advice on its suitability.