Regulatory affairs, pharmacovigilance and market access services in Croatia

With a team of professional, experienced consultants based in Croatia, Grove is a highly-respected provider of pharmaceutical consulting, including regulatory affairs, pharmacovigilance and market access consulting services.

Although the regulatory structures and systems in the Croatian market are broadly transparent, predictable and broadly in line with EU-legislation, understanding the specifics of the regulatory and local pharmacovigilance procedures can be problematic. Challenging terms of business associated with operating in this country (long payment terms, unclear pricing policies and price cuts) reinforces the need for an in-depth understanding of the local reimbursement system and the development of an appropriate approach to pricing and reimbursement submissions. Access to a local regulatory partner and to local QPPV services is an essential pre-requisite to executing successful market entry and development.
As a specialist CEE healthcare consulting firm, Grove’s expertise in Croatia spans four key areas:

  • regulatory affairs consulting, including regulatory intelligence
  • pharmacovigilance services
  • market access, including pricing and reimbursement applications
  • market assessment including opportunity evaluation, regulatory risk assessment and information on medical device regulations


For over twenty years Grove has successfully provided regulatory, PV and market access services to a wide range of clients to help them navigate the specifics of the Croatian market. With experienced consultants based full-time in this country, clients gain access to an unrivalled depth of local knowledge and understanding in all areas associated with entering and operating in the market.

Regulatory affairs, pharmacovigilance, market access and pharmaceutical consulting services are all key areas of expertise for Grove.

Grove services client needs across the following product areas:

  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements