Since 1996 Grove Group provides market entry solutions for the CEE countries. Western pharmaceutical and medical device companies partner with Grove consultants which provide a comprehensive package of regulatory, pharmacovigilance and market access services.
Grove Group Pharmaservices – one partner, multiple solutions
Grove Group services span across:
With our time-proven efficiency Grove Group is a reliable steer for medicines and medical devices to a market with a total population exceeding 270 million people. We are headquartered in the UK and have local professional pharma consultants in Central and Eastern Europe. Grove, a reputable pharma consulting group, represents a strong network of experienced local co-operators based in Poland, Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia, Croatia, Latvia, Estonia, Lithuania, Serbia, Montenegro, Russia, Kazakhstan, Georgia and Armenia.
REGULATORY SERVICES AND REGULATORY SUBMISSIONS IN CENTRAL AND EASTERN EUROPE
Grove Group consultants steer its clients through complex local regulatory requirements to assist with submission of marketing authorization applications and related pharma and medical device registration procedures, post-marketing applications and provision of marketing authorisation maintenance support.
At all times, Grove team maintains close contact and liaises with local health authorities through regulatory submissions to ensure timely responses to state authorities’ requests and demands and adhere to local regulatory requirements and guidelines for medicinal products and medical devices. Medical device regulatory consulting is one of core areas of Grove expertise.
MARKET ACCESS SOLUTIONS
Pricing and reimbursement systems and procedures in the Central & Eastern European countries are notoriously complicated and difficult to navigate. Grove consulting team based in the region advises on reimbursement policy and assists with assessment and submission of reimbursement applications and dossiers.
rove Group local experts have extensive knowledge and experience with preliminary pharmacoeconomicanalysis, HTA (health technology assessment) dossier preparation and HTA submissions.
PHARMACOVIGILANCE SERVICES
Grove has qualified duly trained pharmacovigilance personnel in the countries listed above. It provides a fully comprehensive solution for local pharmacovigilance and vigilance services in the CEE region to pharmaceutical and medical device manufacturers.
The service is continuously developed to ensure that Grove experts are fully compliant with the current drug safety/pharmacovigilance regulations and requirements, both at the European and national levels.
MARKET ASSESSMENT SERVICES
With over 20 years of experience in the Central and Eastern European healthcare sector, Grove consultants have healthcare and pharma markets knowledge which is second to none.
Grove provides ad-hoc consulting services to the companies who look to gain better understanding of the healthcare systems in one or several CEE countries, evaluate the associated market potential and build long term presence in the region. The nature and scope of market assessments varies from regulatory intelligence, reimbursement feasibility studies to expert advice on compassionate use programs or assessment of sales and marketing potential for client’s medicinal products and/or medical devices.
