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Brochure: Clinical Research
ICON's regulatory team provides consulting and operational services to support clients in navigating the fast-evolving regulatory pathway to the successful approval and marketing of their products. Our experts have in-depth experience in the efficient preparation, filing, and post-submission defence of drug and device submissions ranging from US FDA INDs, IDEs, and EU CTXs, to full electronic or paper based NDAs, BLAs and MAAs.
ICON offers end-to-end strategic advice and guidance, beginning with early pre-clinical, CMC, pharmacology and toxicology development. These activities generate the required scientific information necessary to develop the regulatory documentation for submission to a specified regulatory body. If accepted by the regulatory authorities, the client would be authorised to initiate early clinical trials in humans. We can then guide the client on steering the product through a series of further interactions with the regulatory authorities to address important questions including its effectiveness and overall safety when administered in an optimal way to target populations.
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