Regulatory affairs, pharmacovigilance and market access services in Bulgaria

With a team of professional, experienced consultants based in Bulgaria, Grove is a highly-respected healthcare consulting firm providing regulatory, pharmacovigilance and market access services in Bulgaria.

Despite the best efforts to harmonize the regulatory procedures in Bulgaria with the EU, the healthcare sector still has some way to catch up. Pricing and reimbursement processes in Bulgaria are unique, complicated and have historically, discouraged manufacturers from introducing innovative products to the market. Indeed, even generics have been hit by the effects of a price referencing approach unique to Bulgaria.

That said, there is considerable optimism for the future given (a) the potential associated with Bulgarian market itself, (b) the geographical position of Bulgaria as a regional distribution centre within South-East Europe and beyond into Central Asia, and (c) the introduction of a raft of regulatory changes over the past two years to help to improve transparency and predictability in the Bulgarian pricing and reimbursement system.

Gaining a workable understanding of the regulatory requirements in Bulgaria can be difficult. Similarly, administering pharmacovigilance services in the context of the complicated, dynamic Bulgarian market can also prove challenging. Likely further legislative change simply reinforces the need for an in-depth understanding of the current and likely evolving reimbursement system in Bulgaria and the development of an appropriate approach to pricing and reimbursement applications in Bulgaria. Access to a local regulatory affairs specialist in Bulgaria and to local QPPV services in Bulgaria is an essential pre-requisite to executing successful market entry and development.

As a specialist in pharmaceutical consulting in Bulgaria, Grove expertise spans four key areas:
  • regulatory consulting; regulatory submissions
  • pharmacovigilance services
  • pricing and reimbursement strategies and applications
  • market assessment including regulatory intelligence such as pharma and medical device regulations

GROVE AS YOUR PARTNER IN BULGARIA FOR REGULATORY AFFAIRS, PHARMACOVIGILANCE AND MARKET ACCESS

For over twenty years Grove has successfully provided regulatory affairs consulting in Bulgaria to a wide range of clients to help them navigate the specifics of the market. With experienced local consultants, clients gain access to an unrivalled depth of local knowledge and understanding in all areas associated with entering and operating in the country.

Pharmaceutical consulting, regulatory affairs, pharmacovigilance and market entry related services are all key areas of Grove’s expertise.