Regulatory consulting case studies
Delivering strategic regulatory consulting across the product life cycle
Encompassing over 1,000 experts across more than 90 locations we deliver customised, end-to-end regulatory solutions tailored to your needs.
Supporting an ANDA submission for a drug-device product
A Canadian mid-size pharma company partnered with ICON to support FDA approval of a generic injectable for opioid overdose treatment. ICON’s Regulatory Affairs team guided the sponsor through the ANDA process, including pre-submission, filing, and responding to FDA review queries.
Eliminating enrolment delays to bring an AI-enabled SaMD to market
A medical device developer faced clinical evaluation timeline delays due to under-enrolment. Discover how the collaborative partnership between the sponsor and ICON’s Medical Device & Diagnostics Research team steered the study from patient enrolment to FDA submission and approval.