Regulatory consulting case studies

A small Asia-based biotech engaged ICON to manage its EU orphan drug designation submission for a treatment targeting Dercum’s disease. The designation was key to supporting a planned Phase 3 study and expanding into the EU, where the company had no existing presence.

A midsize pharma company based in the EU contracted ICON to support a New Drug Submission in
Canada for a respiratory drug for chronic obstructive pulmonary disease

A CRO managing a Shared System REMS engaged ICON Regulatory Consulting to support a Type V Drug Master File since 2016, covering four branded and 200 generic products. Following the FDA’s 2020 guidance on structured product labeling (SPL), ICON prepared the REMS SPL to meet the December 2022 compliance deadline.

An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. ICON Regulatory Consulting was engaged to support market entry.

As a result of the comprehensiveness of the documentation and the efficient management of the process, the European Commission granted both indication extension and the additional year of market exclusivity.

Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. ICON’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.

A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.

A Europe-based biotech preparing for a phase 1/2a oncology trial turned to ICON for support during their first IND submission. With limited FDA experience, they relied on ICON to navigate the 30-day review period and respond quickly to agency requests.

An international biopharmaceutical company based in the EU contracted ICON to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration.

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.

ICON stepped in when a biopharma company required urgent rescue assistance with two phase 3 trials for Hidradenitis Suppurativa (HS) and Psoriatic Arthritis (PsA).

RIM System Configuration and Data Assessment is pivotal in regulatory business planning. It also helps in organising product registration process to track and manage all regulatory activities.