With offices close to both the EMEA and FDA, a network of international expertise and a customer focused approach, we are committed to delivering superior quality regulatory services that enable our clients to expedite drug development programmes. With our extensive experience in regulatory affairs and drug development, we understand the financial burden and time pressures in drug development 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.

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.

In addition to regulatory professionals with broad therapeutic expertise and experience with the Centralised, Decentralised and Mutual Recognition procedures as well as NDAs, the ICON regulatory team also includes experts with industrial experience within the specialist disciplines of quality, non-clinical and clinical, who have a sound knowledge and understanding of the philosophy and requirements of the FDA, EMEA and other international regulatory authorities and are able to offer strategic input into the development of your product.

We pride ourselves in providing a service of the highest quality delivered within pre-agreed timeframes. Our focus is always the needs and best interests of our client.