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
IN CENTRAL AND EASTERN
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.
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.
Grove Group local experts have extensive knowledge
and experience with preliminary pharmacoeconomicanalysis, HTA (health technology assessment)
dossier preparation and HTA submissions.
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.
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
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.