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CambReg and SIRO forge strategic alliance

Published on 21/09/09 at 11:06am

UK contract research organisation Cambridge Regulatory Services has teamed up with one of its Indian counterparts - SIRO Clinpharm - in order to help generics companies from India and elsewhere bring products to market in the European Union.

The two CROs say that the EU market can be challenging for companies with relatively limited resources as it is "patchwork of small to medium-sized markets with varying regulatory and economic barriers to entry".

The partners point out that companies trying to bring generics to the European market are required to file multiple national marketing applications and, in some cases, may also be asked to carry out small 'bridging' clinical trials to satisfy local regulatory demands.

The two CROs aim to provide small and mid-sized companies with a complete suite of regulatory services for registering human medicines in the EU, including small-molecule and biologic drugs and medical devices.

Put simply, the alliance combines SIRO's clinical trial network in Europe with the regulatory expertise offered by CambReg, and is designed to simplify the development and registration process.

Karen James, managing director of CambReg, said: "Often companies have to look for multiple vendors to register their products in Europe.

"CambReg's pan-European regulatory expertise coupled with SIRO's abilities to conduct fast paced trials in Europe will provide clients with a one-stop and cost effective solution for their European registration needs," she added.

SIRO has a long heritage in providing clinical trial services in India but is a relatively recent player in Europe, finding its roots in the market via the acquisition of mid-size Germany CRO Omega Mediation Group in 2008.

The Omega deal and subsequent expansion brought it operations in Germany, Romania, Estonia and Greece, and the firm has recently opened additional offices in the Czech Republic and Spain.

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