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QUALITY DOCUMENTS FOR R&D

For novel therapeutics to reach the clinic and then the market, their development must satisfy the requirements of the regulatory or accrediting body (for example, Australia's Therapeutic Goods Administration, National Association of Testing Authorities or the US Food and Drug Administration). This requirement is also becoming an important pre-requisite before industry investment into a potential therapeutic.

Establishing and maintaining such accreditation is highly time and resource intensive, often taking over a year and many hundreds of thousands of dollars. To accelerate this process, Therapeutic Innovation Australia (TIA) has established iQDOCs, a repository of over 500 open-access generic documents that can be freely downloaded by publically funded researchers and adapted for use in establishing quality systems.

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