Cambridge Regulatory Services forms partnership with SIRO Clinpharm of India

Published: 18-Sep-2009
Media Regulatory

Cambridge Regulatory Services (CambReg) is to conduct fast-paced clinical trials with SIRO Clinpharm, a global India-based clinical research organisation.


Cambridge Regulatory Services (CambReg) is to conduct fast-paced clinical trials with SIRO Clinpharm, a global India-based clinical research organisation.

CambReg's regulatory expertise, coupled with SIRO's abilities to conduct speedy trials, will provide clients with a one-stop, cost-effective solution for all their registration needs, the company says.

"This partnership will provide European pharma companies with increased confidence in accessing cost-effective clinical trial solutions, hence introducing new clients to SIRO. In return, SIRO will have the benefit of offering regulatory expertise through CamReg," says CambReg's managing director Karen James.

"Our alliance with CambReg would go a long way in helping small- and mid-sized companies cut through the regulatory maze in Europe," added Dr Chetan Tamhankar, chief operating officer of SIRO Clinpharm. "This alliance builds on the strength of our European clinical trial operations and allows us to offer greater value to our clients."

The alliance will offer full regulatory services to pharma companies wishing to register human medicines, including new small molecule or biotech entities, biologics, herbals and generics. Services include preparing clinical trial applications, marketing authorisation applications in eCTD format, specialist paediatric investigation plans and paediatric use marketing authorisations, as well as managing decentralised and mutual recognition procedures across the European Union.

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