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Welcome to Bionex

Bionex’s mission is to realize bio-pharmaceutical and life sciences into commercial products and services that benefit human health. Strategically, Bionex engages in two areas of business activities. First, Bionex offers contract R&D services, from early-stage concept development to full-scale commercialization, in bio-pharmaceutical, food and cosmetic products. Second, Bionex develops and out-licenses its own proprietary formulations, technologies, and products related to drug, health food, and skin-care applications. In December 2009, Bionex was presented with a Success Award by NJSBDC (New Jersey Small Business Development Centers) for its success in development and implementation of its novel drug delivery technologies.

 

NJSBDC Award

In December 2009, Bionex was presented with a Success Award by NJSBDC (New Jersey Small Business Development Centers) for its success in development and implementation of its novel drug delivery technologies.


Regulatory Experience

Bionex has several consultants that have expertise in developing regulatory strategies, experience with US FDA and international regulatory ICH Guidance documents governing pharmaceutical product development and compliance with ICH and US FDA GMPs, GLPs, GCPs and GxPs in pharmaceutical development and commercialization of products. The company relies on consultants to formulate its regulatory product development strategies and interactions with FDA in filing pre-IND meeting requests, INDs, IND amendments and 505(b)(2) NDAs.




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