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 that enable our clients to expedite drug development programmes. We work in partnership with our clients to maximise opportunities and meet key milestones on time and on budget.

Our staff have the experience and knowledge to support your needs throughout the entire product lifecycle, from 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.

We are flexible to the individual requirements of our clients and tailor our services to meet our clients’ short- and long-term needs, whether they are small companies driving their drug portfolio through early development and require assistance with clinical trial submissions or Regulatory Authority Consultation, or medium to large sized companies submitting an MAA and/or NDA, or requiring support with post-licensing activities.

Our regulatory professionals have broad therapeutic expertise and experience. The teams are located in our main offices in the EU (London and Dublin) and USA (New York and North Wales) and have a presence in ICON offices worldwide. In addition, ICON utilises a well established network of international consultants.

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.