For some drugmakers familiar with the US regulatory system, European drugs laws can be something of a daunting proposition, particularly if the firm in question is lacking in resources.
Whether it be the need to register new generic products in each country or the requirement to conduct bridging studies, for some, the barriers to entry can seem insurmountable.
Siro and CambReg’s new partnership is designed to address these issues and help clients gain approval for products in Europe, by combining the former’s European trial operations with the latter’s knowledge of regional drug laws.
Under the deal, Siro and CambReg will offer help preparing CTAs, MAAs, PIPs and PUMAs across the whole continent, as well as providing consultancy services with the European Medicines Agency (EMEA).
Siro’s chief operating officer, Chetan Tamhankar, stressed potential regulatory pitfalls, describing Europe’s drug laws as a regulatory “maze” and suggested that the new alliance will help “small and midsized companies” bring drugs to market faster and more efficiently.
CambReg’s managing director, Karen James, agreed, reiterating that: “Often [drug] companies have to look for multiple vendors to register their products in Europe.”
She added that CambReg’s experience of regulations coupled with Siro’s trial locations in countries like Germany, Romania and Greece, as well as new offices in Spain and the Czech Republic, will create a one-stop, cost effective solution.
While Big Pharma is clearly more than capable of navigating Europe’s complex regulatory path, small and medium sized drug firms wanting to launch products in the continent are likely to be attracted by any service that helps ease the process.
This demand for regulatory is likely to increase in the future as more single-product biotech firms emerge that do not have the expertise required to gain approval in Europe.
Additionally, with the pharmaceutical industry’s eye being increasingly drawn by emerging markets, specialist knowledge of laws in countries in Central and Eastern Europe is likely to become highly sought after in years to come.