Pharma Support Services Ltd - your regulatory and pharmaco vigilance provider in Eastern Europe
Achieving compliance with local requirements can be a tough deal and an unexpected challenge sometimes -
Achieving compliance with local requirements can be a tough deal and an unexpected challenge sometimes
Hence you need a partner you can trust
Given the diversity of the Eastern European region and the fact that the languages spoken are very different from one another (as both Cyrillic and Latin alphabets are used in the region dependent on the country) launching your products can be a challenge. It needs to be matched with a local expertise in regulatory affairs, pharmacovigilance and pricing - all of which are essentials for speedy access to Eastern European markets. Whether you are only exploring possibilities to expand or already have presence in Eastern Europe we can adapt our services to be of help to your business.
As a first prerequisite we ensure you receive a well-grounded legal advice and country-specific background. Based in Sofia, Bulgaria and having reliable partners all over Eastern Europe, we can find the right partner for you should you be looking for a GMP, GDP compliant warehouse or support with medical devices and medicinal products registration and their pricing and reimbursement possibilities. As the healthcare systems in many of the countries in the region are based on the so-called „external reference pricing system“ we can provide guidance on which countries are included in the reference basket and what strategy can be adopted to secure your product on the market.
we can find the right partner for you should you be looking for a GMP
Worried about Brexit outcome?
Further down the line of establishing in your business in Eastern Europe we are happy to support you with transfer of marketing authorisations, finalization of national phases of your DCP/MRP applications as well as start a national authorisation procedure for your product, should you be interested in one market only. We have a broad expertise in registration and communication of all necessary requirements so that you can focus on marketing your products while we do the rest.
In addition to local pharmacovigilance point of contact as well as literature screening of non-indexed journals and publications we perform follow-up assessment of relevant articles/scientific extracts. Medical review of cases published in literature can help you identify important signals concerning the safety profile of your products. And a lot of locally issued journals are not indexed by Embase and Medline, so we can provide further assistance with these issues.
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