To facilitate 505 (b) (2) NDA pathway using cloud based regulatory intelligence

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Kishor Kumar Chakraborty

Riyadhpharma, KSA

: J Pharm Drug Deliv

Abstract

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Real World Data (RWD) analytics using cloud based development support are transforming the R&D landscape (scalable approaches to data stewardship and data integration) through rapidly find external studies relevant to product, indications, and safety concerns without having to providing every possible keyword or synonym, without an ontology, and without accessing multiple tools and repositories. Through the use of latent semantic indexing—which uses algorithms to automatically generate keyword synonyms and concepts for searches—platform will provide all of the relevant studies, articles, and published materials from across all the information sources available. The results are delivered quickly and accurately, and facilitated regulatory intelligence for increasingly utilized 505(b) (2) NDA pathway to bring improved and differentiated products to market faster and more cost effectively. New indications for existing drugs is an extremely lucrative business opportunity and accelerate drug repositioning to reach conclusions without having to conduct expensive laboratory research is a prospect definitely worth evaluating.

Biography

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Email: kishorc@riyadhpharma.com