An Investigation New Drug (IND) Application is a request for FDA
authorization to administer an investigational drug to humans. IND
packages may include:
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Manufacturing information: the composition,
manufacturer, stability, and control measurements used for manufacturing
the drug substances and the drug products. This information is
assessed to ensure that the company can adequately produce and supply
consistent batches of the drug.
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Animal pharmacological and toxicological
studies: preclinical data to permit an assessment as to whether the
product is reasonably safe for initial testing in humans.
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Clinical protocols and investigator information:
detailed protocols for proposed clinical studies to assess whether the
initial-phase trials will expose subjects to unnecessary risks. Also,
information on the qualifications of clinical investigators who oversee
the administration of the experimental compound should be included in
order to assess whether they are qualified to fulfill their clinical
trial duties.
Service
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Preparing and organizing Pre-IND meeting
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Organizing and reviewing available material
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Raw materials and products
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Process and control
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Preclinical trial data
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Clinical trial data
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Developing protocols for phase I clinical trial
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Preparing and organizing materials and presentation files for Pre-IND meeting
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Key opinion leaders (KOL) recruitment
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Correspondence with FDA and holding Pre-IND meeting
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Rectification according to FDA’s advices
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Preparing and submitting IND package
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Preparing and organizing IND data
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Principal investigator (PI) of clinical trials recruitment
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Selecting clinical trial sites
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IND drafts review and final versions
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Submitting IND to FDA as the US agent
Link to "Services" for more information.
