i3 hopes ChinaGate opens path to regulatory success

By Gareth Macdonald

- Last updated on GMT

Related tags: Clinical trial

i3 has bought contract regulatory services firm ChinaGate to build in China’s rapidly expanding drug and device clinical research market.

US-based i3, a unit of Ingenix, said the Shanghai firm’s local knowledge and expertise, coupled with its experience of the State Food and Drug Administration (SFDA), will help customers expand in China.

The New Jersey firm went on to explain that, since its foundation in 2002, ChinaGate has provided trial oversight and regulatory support services to drug, device and biotech companies, resulting in the launch more than 450 products.

For example, in March ​2008, Japanese drug discovery and development firm ClioScience teamed up with ChinaGate in a bid to expand its presence in China’s clinical trials market.

This track record was a key driver for the deal according to i3 CEO Glenn Bilawsky who said ChinaGate: “will enhance i3's ability to help our customers expand and sustain their business in the important Chinese market​.”

China R&D expansion

The other obvious motivation for the i3 ChinaGate deal is the likely increase in demand for regulatory consulting if the Chinese Government's plans to invest 2.5 per cent of GDP in pharmaceutical R&D come to fruition.

Such investment, which would be comparable to the level currently spent on drug R&D in the US, will create significant opportunities for both domestic and international pharmaceutical firms and CROs.

This, in turn, is likely to increase demand for regulatory support services, particularly from overseas companies which may not be overly familiar with rules that govern drug approvals in the country.

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