We have set up a new formulation unit for sterile small volume liquid
products, using Blow-Fill-Seal technology. We are now planning to
enter the regulated pharmaceutical markets of US, Europe, Brazil.
We are developing ophthalmic Suspension/ emulsion formulation
(Generic Product) for regulated market like ANDA, first to file. Our
products are under development phase.
We need to evaluate the feasibility of projects in terms of clinical
trial activity (Phase III).
For your information, drug is indicated for open angle glaucoma.
You are kindly requested to suggest probable information about
following queries:
1) Is it required for organization (CRO) to be approved by
regulatory bodies viz US FDA, MHRA, and ANVISA for conducting
clinical trial?
2) How many number & type of patient would be required for
conducting clinical trial (phase III) on ophthalmic molecule?
3) How & who will approve study protocol?
4) Does the clinical trial conducted in India will be
acceptable in above said countries?
We are looking forward to hear you!
Best regards
Prasoon Mishra
Sr. Executive - Business Development
Corporate Office, New-Delhi (India)
PROMED Exports Pvt. Ltd.
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