1. An introduction to a new service.
We have now been working in SE Asia for some time. We have observed the increasing number of companies,
especially from the Indian subcontinent who wish to use the excellent environment of APAC to develop their drugs in
a welcoming and high-quality environment; but so often problems are encountered and perceptions of regulatory
requirements are sometimes wrong
Having helped some clients through this hurdle we have come to recognise a real need for a formalised service
which we have not developed as ‘Fusion Fix-it’.
By approaching us through the Fusion system, we are able to apply the experts you need to provide all the services
applicable to APAC.
Regulatory support. Including taking your product through Regulatory submission in APAC.
We have special knowledge of Malaysia, Indonesia and Australia.
Introduction to manufacturing and formulation sites meeting local requirements.
The APAC countries have different requirements from one another. We will guide you accordingly depending
on the best site for your drug development programme.
Presentation of Investigator brochure and Toxicology packages.
We will perform a gap analysis of your package and introduce you to, or organise pre-clinical studies in an
APAC location using our partners. We will provide full GLP compliant laboratory facilities.
Clinical programme design utilising the sites and populations of APAC.
We have within our group, Phase I/2a capability in both healthy volunteers and special ethnic populations
applicable to the region (including those for Japanese registration) We also have an oncology Phase I Unit in
a well-equipped hospital with full laboratory and imaging facilities.
Full bioanalytical, special assay and Data management//Statistics across the region.
our bioanalytical tam is well known both for its small molecule and large molecule and immunogenicity
We have special understanding of the issues of biosimilars and vaccines.
Through our Dubai-based member, JVLT, we will try and assist companies to source Arabia-based
investors We have a novel investment platform using Limited Liability Partnerships which lends itself well
to the Islamic investor.
If you have a drug development project which might benefit from the environment of APAC then please approach, in
the first instance Elizabeth Stevens who will co-ordinate a group of our experts tasked with making a preliminary
analysis of your needs and will try and identify how we can assist you.
CONTACT: Elizabeth Stevens
elizabeth.stevens@gvjlt.com (investment)
or, Elizabeth.stevens@fusionseasia.com (science and drug development)
for a first interaction with our group.