Regulatory Support in Phase IIb-III

ICON has the expertise to support you with the additional regulatory input required when moving on to confirmatory development and beyond. With the constant evolution of healthcare legislation and increasing attention to patient safety, we are aware of the complexity of challenges that you may have to face as your compound progresses along the regulatory pathway.

At this stage we can provide you with a framework within which you will be able to plan continuing clinical trial submissions in parallel with your marketing authorisation applications. We have a proven track record of successfully managing Regulatory Authority liaisons at this stage.

We can help you optimise the way forward for your compound and we can assist with planning and implementation of regulatory strategies for marketing authorisation submissions to the Centralised, Decentralised and Mutual Recognition Procedures within the EU (including translation management), as well as submissions to the FDA, including preparation of CTD/eCTD modules 1 to 5. Specifically, our consultants have experience with Risk Management Plans, Environmental Risk Assessments and patient and prescribing information development (including PIL User Testing), as well as with non-clinical and clinical summaries and overviews, and Quality Overall Summaries.

Management of your submission through validation, assessment and conclusion of regulatory approval is essential, and we support our clients through all negotiations with regulatory authorities.
Flexibility is a key aspect of ICON’s services. We design a package of services to meet your particular requirements whether you require full or partial service arrangements with your CTD.