Regulatory affairs, pharmacovigilance and market access services in Romania

With a team of professional, experienced locally based consultants, Grove is a highly-respected provider of pharmaceutical consulting in Romania, including but not limited to regulatory affairs, pharmacovigilance and market access services.

Despite greater relative transparency in terms of the local pharmacovigilance processes, implementing the appropriate systems and meeting EU and national requirements is not without its challenges given the complex and dynamic local regulatory affairs environment. Similarly, while the regulatory affairs area itself appears on the face of it to be logical and workable, without an in-depth understanding of the local structures, systems and dynamics, interpreting the local regulatory and pharmacovigilance requirements can be extremely difficult.

Likely further 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 your healthcare consulting firm in Romania and its expertise spans four key areas:

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


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 Romanian market. With experienced locally based 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, market access and market assessment 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