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SIRO Clinpharm and CambReg Ltd Strategic Alliance to offer regulatory services in Europe.
Alliance will offer a one stop solution to pharmaceutical companies looking to register their products in the lucrative European markets.
Mumbai-India and Cambridge-UK, Aug 18th 2009 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 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, Ms. 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 whole of
the EU as well as consultancy for any issues with regulatory authorities.
About SIRO
SIRO Clinpharm Private Limited (SIRO) is among one of the leading global Clinical Research Organizations (CROs),
offering full scope services, 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 at Germany, Romania, Estonia and Greece. SIRO has recently opened offices in
Czech Republic & Spain.
About CambReg
CambReg, established in 1999 is a full service regulatory services company based in Cambridgeshire, UK. It helps
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 exhealth 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
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