Regulatory affairs, pharmacovigilance and market access services in Serbia

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

Understanding the complex local regulatory affairs and pharmacovigilance requirements is challenging. While there is a drive towards harmonization with the EU given the country’s anticipated future accession to the EU, the regulatory system remains complex and bureaucratic. Likely legislative change 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.

Grove is a healthcare consulting firm and its expertise in Serbia 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 insights related to 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 Serbian 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 Serbian market.

Pharmaceutical consulting, regulatory affairs consulting, pharmacovigilance, market access and market assessment services are all key areas of Grove expertise.

Grove services client needs across the following product areas:

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