GDFI has focused on a win-win strategy through globalization
by cooperative system between
domestic CRO(GDFI) and Multinational CRO. In order to support
a new drug development and launch in global market the process
of a new drug development includes preclinical studies, Phase
I, Phase II,
Phase III and Phase IV globally after NDA (New Drug Approval).
For the rapid progress of clinical trials, GDFI has established
partnership with Global CROs having
expertise in pharmaceuticals and medical device etc. and plays
the role as a collaborator during all
phases of new drugs and medical devices development.
Establishing partnership with Global CROs, GDFI holds CRO
networking to meet the requirements of
a sponsor. GDFI maintains the most updated and the best quality
and please do not hesitate to ask us if you need any help for
a new product development.
CRO, HQ located in Fukuoka, branch offices in Tokyo, Osaka, Translation
Institute in Kurume Univ. Since Jan 2007, GDFI has been cooperated
with IBERICA in Clinical Development, Clinical Pharmacology, and
Comprehensive Consultancy Service. Main expertise is in Metabolite
and Proteome Analyses.
based CRO, it conducts various CRO services in Biocompatibility,
Biological Safety, Marketing Analysis, Competitive intelligence,
Marketing intelligence, Training & Education etc. Especially
its expertise lies in medical devices.
A full-service CRO, founded in 1987, headquartered in Germany with regional offices in USA, UK, Belgium, France, Italy, Spain, Austria, Israel, Russia, Ukraine, and Poland. It obtains core competiveness in all clinical trials for pharmaceuticals as like new drug, bio similar and all classes of medical devices. Also it was awarded the Gold Award for 10 years of certified compliance with ISO 9001 standards by LRQA and completed to the satisfactory compliance result in FDA inspection in 2009 in trial management, regulatory and ethics committee submissions, monitoring, DM (data management), and statistics services of a pivotal Phase III study with FDA and other relevant standards.