The Czech Republic benefits in very many ways from its geographical proximity both to large western European markets on the one hand, and also from its position within the Central and Eastern European region. It further benefits from a sophisticated infrastructure, high quality of living and a talent pool that is the envy of many. For those involved in the pharmaceutical industry, the local regulatory affairs and associated regulatory processes are both transparent and predictable. Recent changes within the regulatory environment have been conservative, but this has been to the benefit of both those established in the Czech Republic and new entrants as manufacturers have been able to anticipate change and plan and implement appropriate strategies accordingly. That said, the local pricing and reimbursement system remains stubbornly complex.

Despite the clear positives associated with the market, an in-depth understanding of the regulatory and local pharmacovigilance processes is vital for any potential new entrant. Product registration can be managed with relative ease compared to many other Central and Eastern European markets. That said, many do still struggle to fully understand the local reimbursement system and are consequently poorly placed to develop an appropriate approach to pricing and reimbursement submissions. Access to a local healthcare consulting firm and to local QPPV services is absolutely vital to the development and execution of successful market entry and development strategies.

Grove is your healthcare consulting firm in the Czech market 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 opportunity evaluation, intelligence on medical device regulations in the Czech Republic and regulatory risk assessment

GROVE AS YOUR LOCAL REGULATORY AFFAIRS CONSULTING

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 consultants based full-time in the market, 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.