SIRO Clinpharm, the international contract research organisation (CRO) based in Mumbai, India, has forged a strategic alliance with CambReg Regulatory Services to help companies register their products in European markets.
The alliance, which builds on SIRO Clinpharm’s existing clinical trial operations in Europe, will “go a long way in helping small and mid-sized companies cut through the regulatory maze in Europe”, said the CRO’s chief operating officer, Dr Chetan Tamhankar.
The alliance with CambReg, a UK-based regulatory services company with clients in Europe, America and Asia, will offer a full range of services including preparation of Clinical Trial Applications; Marketing Authorisation Applications in eCTD (electronic Common Technical Document) format; Paediatric Investigation Plans (PIPs); Paediatric Use Marketing Authorisations (PUMAs); managing submissions through the decentralised procedure/mutual recognition procedures; and consultancy on any issues arising with regulatory authorities.
With a patchwork of small to medium-sized markets and varying regulatory/economic barriers to entry, including the need to register new generic drugs in each EU country, Europe is a complex proposition for these and other products, the new partners observed. Many regulators also require bridging studies before they will grant marketing approval.
“Often companies have to look for multiple vendors to register their products in Europe,” commented CambReg managing Karen James. “CambReg’s pan-European regulatory expertise, coupled with SIRO’s abilities to conduct fast-paced trial in Europe, will provide clients with a one-stop and cost-effective solution for their European registration needs.”
Complementing its presence in India, the US and Israel, SIRO ClinPharm has European offices in Germany, Romania, Estonia, Greece, the Czech Republic and Spain.
