MUMBAI, India and CAMBRIDGE, England, Aug. 25 /PRNewswire/ -- SIRO Clinpharm, a leading Indian MNC CRO, and CambReg Regulatory Services, a UK-based pan-European regulatory services provider, announced today the formation of an exclusive strategic alliance to help companies register their products in the European market.
Unlike the US, Europe is a patchwork of small to medium-sized markets with varying regulatory and economic barriers to entry, including a requirement to register new generic drugs in each EU country. Many EU regulators also require small clinical trials called bridging studies to be conducted before marketing approval is granted. These two factors make the introduction of generic and other products in Europe a complex affair.
"Our alliance with CambReg will go a long way in helping small and midsized 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," he added.
Commenting on the alliance, 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."
The alliance will offer full scope regulatory services to companies wishing to register human medicines of any kind including new small molecule or biotech entities, Biologics and Herbals as well as Generics. Services include preparing CTAs, MAAs in eCTD format, PIPs, PUMAs, etc and managing DCP/MRP across the EU as well as consultancy for any issues with regulatory authorities.
SIRO Clinpharm Private Limited (SIRO) is among one of the leading global Clinical Research Organizations (CROs), offering full scope services and conducting clinical trials in the Pharmaceutical, Biotechnology and Medical Devices sectors in compliance with international standards. SIRO is one of the first CROs founded in India, which caters to the needs of pharmaceutical companies across the world. The company has offices in India, USA, Israel and in Europe in Germany, Romania, Estonia and Greece. SIRO has recently opened offices in the Czech Republic and Spain. More information about SIRO is available at www.siroclinpharm.com.
CambReg, established in 1999, is a full service regulatory services company based in Cambridgeshire, UK. It assists pharmaceutical and biopharmaceutical companies with regulatory affairs advice, submissions and compliance. It has provided services to over 200 clients based in Europe, America and Asian countries. The founder directors are ex- health authority staff and have over three decades of experience with European regulatory affairs. CambReg has Investors In People status in the UK. More information about CambReg is available at www.cambreg.co.uk .
|SOURCE SIRO Clinpharm|
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