Cambridge Regulatory Services (CambReg) has formed a strategic alliance with SIRO Clinpharm, a clinical research organisation. The new alliance will provide benefits to pharma companies in both Asia and Europe.
Karen James, managing director of Cambridge Regulatory Services, said: “Having come highly recommended to CambReg by the Mumbai High Commission, we are extremely pleased to be endorsing this alliance with SIRO today. 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 CamReg.”
Chetan Tamhankar, chief operating officer of SIRO Clinpharm, said: “Our alliance with CambReg would go a long way in helping small and mid-sized companies cut through the regulatory maze in Europe. This alliance builds on the strength of our European clinical trial operations and allows us to offer greater value to our clients.”
The new alliance will offer full regulatory services to pharma companies wishing to register human medicines, including new small molecule or biotech entities, Biologics, Herbals and Generics. Services include preparing Clinical Trial Applications, Marketing Authorisation Applications in eCTD format, specialist Paediatric Investigation Plans and Paediatric Use Marketing Authorisations, as well as managing Decentralised and Mutual Recognition Procedures across the whole of the EU.