As a result of EU membership, local pharmacovigilance procedures are relatively transparent. Despite the obvious will of the national regulatory authorities to improve transparency and predictability within the regulatory affairs however, understanding and navigating local pricing and reimbursement policies remains difficult. Likely future 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 in the country. 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 specialist CEE focused healthcare consulting firm and its expertise in Lithuania 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, intelligence on medical device regulations and routes to market

GROVE AS YOUR PARTNER IN LITHUANIA 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 Lithuanian 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 Grove local expertise.