A specialized consultancy company focused on supporting you to achieve compliance with the local requirements on Bulgarian and Romanian markets prior to launching your products with a broad expertise in regulatory affairs, pharmacovigilance and pricing and reimbursement services  - all of which is essential for speedy access to Eastern European markets.

As a prerequisite for your business we ensure you receive a well-grounded legal advice and country-specific background. We can even find the right partner for you should you be looking for a GMP, GDP compliant warehouse or support with medical devices and medicinal products licensing and notifications. All paperwork and applications can safely be trusted to us. We will keep you informed at every step of the process.

Further down the line of establishing your business in Eastern Europe we are happy to support you with the 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.

One of our flagship services throughout the years is of local pharmacovigilance contact in Bulgaria and Romania as well as literature screening of non-indexed journals and publications with a 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. Should you wish to find out more please contact us for further info

Worried about Brexit outcome?

We offer full-fledged services including marketing authorisation transfers, opening a company in various EU countries amongst which Bulgaria where the corporate tax is only 10% and the timeline for transfer of authorisations is just three months.

Contact us for more information on this service and the countries we can support you in.



Pharma Support Services Ltd 

Your regulatory and pharmacovigilance provider in Bulgaria and Romania

Pharma Support Services Ltd. || Regus Sofia City West,53-55 Totleben blvd. || Sofia 1606, ||  Bulgaria

Regus Green Gate || 22 Tudor Vladimirescu Blvd., Sector 5, || Bucharest, 050 883, Romania