Despite its small size, the local regulatory system remains less than optimal in terms of transparency. Understanding the local regulatory and pharmacovigilance procedures is difficult. The widespread lack of transparency and predictability within the regulatory system 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 Montenegro 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, information on medical device regulations and routes to market

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

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 local 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, market access and market assessment services are all key areas of Grove’s expertise.