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payment terms after registration. Luckily factory visit is not required till this year but
WHO-GMP is minimum requirement for factory.CTD format dossier is required along
with PSUR (periodic safety update report) as per ICH guideline. BA/BE study is also
required in case of few tablet and capsule formulation. Clinical trial is required if your
formulation is not approved with Uzbekistan FDA. Government fee is USD 6500 per
product for registration and registration time ranges from 6 months to 12 months
depending upon your dossier quality and follow ups with FDA people. Registration
will be renewed after every 5 years. Don,t you feel that registration fee is too high, it
is because you are getting 32 million population market.
You can establish your own representative office, distribution center and your own
sales team to get better and faster business. Through this strategy you can manage
well your ROI. There are service providers in India and in Uzbekistan who can assist
you in establishing your office, recruiting staff, arranging visa, liosoning with
government officials.
Margins are good in comparison to African and Asian market. You can overcome
your expenses in very first order, all depends on business strategy, implementation
and control. Your product basket should be need of the hour and valuable in terms of
financial terms so that you can overcome your cost and profit margins. Keep abreast
closely about what is happening into the market place. You cannot leave everything
on team, your visit as an owner is mandatory and it should be regular.