Regulatory Affairs


At ICON we understand the needs of our customers and the importance of sound regulatory strategies within a complex and ever-changing environment.

With a network of international experts and a customer focused approach, we are committed to delivering superior quality regulatory services and work in partnership with our clients to maximise opportunities and meet key milestones on time and on budget.

Our staff has the experience and knowledge to support your needs throughout the entire product lifecycle, from early consultations defining the regulatory development strategy, to clinical trial and marketing authorisation submissions, through to post-licensing support.

Our service portfolio ranges from NCEs, to biological/biotechnological products and generics. In addition, due to our in-house expertise in drug-device combination products and medical devices, we can offer a range of strategic and operational services, including clinical investigation submissions and CE-marking expertise.

Our regulatory professionals have broad therapeutic expertise and experience with Centralised, Decentralised and Mutual Recognition procedures.and NDAs. We pride ourselves in providing a service of the highest quality delivered within pre-agreed timeframes. Our focus is always on the needs and best interests of our clients.