Cambridge Regulatory Services (CambReg) has formed a strategic alliance with SIRO Clinpharm, a global Indian-based CRO, to provide services to pharma companies in both Asia and Europe. The alliance combines CambReg’s regulatory expertise with SIRO’s clinical trial services.

The alliance will offer full regulatory services for registering human medicines, including new small molecule or biopharmacetical entities, biologics, herbals and generics. Services include preparing clinical trial applications, marketing authorization (MA) applications in eCTD format, pediatric investigation plans and pediatric use MAs, as well as managing decentralized and mutual recognition procedures across the EU.

“Having come highly recommended to CambReg by the Mumbai High Commission, we are extremely pleased to be endorsing this alliance with SIRO,” said Karen James, managing director of Cambridge Regulatory Services. “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 CambReg.”

“Our alliance with CambReg would go a long way in helping small and mid-sized companies cut through the regulatory maze in Europe,” said 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.”

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