The Mumbai-based Contract Research Organisation (CRO) SIRO Clinpharm has entered into a pact with the UK-based pan-European regulatory services provider, CambReg Regulatory Services to support companies register their products in the European market.
The alliance will offer full regulatory services to companies looking to register human medicines including new small molecule or biotech entities, biologics and herbals as well as generics. The company will provide services include preparing CTAs, MAAs in eCTD format, PIPs, PUMAs, etc and managing DCP/MRP across whole of the EU as well as consultancy for any issues with regulatory authorities, announced SIRO Clinpharm.
"Our alliance with CambReg would 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 ability to conduct fast paced trials in Europe will provide clients with a one-stop and cost effective solution for their European registration needs."
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, according to the company officials.
CambReg, established in 1999 is a full service regulatory company providing support to pharmaceutical and biopharmaceutical companies with regulatory affairs advice, submissions and compliance. The company has provided services to over 200 clients based in Europe, America and Asian countries.