Regulatory consulting case studies
Delivering strategic regulatory consulting across the product life cycle
Encompassing over 1,000 experts across more than 100 locations we deliver customised, end-to-end regulatory solutions tailored to your needs.
Regulatory support for Asian biotech’s EU orphan drug designation
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.
Strategic problem-solving for a complex Canadian New Drug Submission
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
Canada for a respiratory drug for chronic obstructive pulmonary disease
Meeting new REMS SPL guidelines 22 months before they became mandatory
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.
Enabling US and EU market entry for neurodegenerative disease treatment
An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. ICON Regulatory Consulting was engaged to support market entry.
Regulatory problem-solving secures crucial extensions in pediatrics and rare disease
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.
Regulatory solutions for uncharted scientific waters
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.
Use of Real World Data to fulfil post-approval requirements
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.
Overcoming time zone and knowledge gaps to gain FDA IND study approval
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.
CMC and local regulatory expertise deliver timely anti-cancer drug approval
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.
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.
Exceeding expectations for late-stage rescue study success
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 Data and System Assessment to ensure IDMP compliance
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.
Regulatory support for Asian biotech’s EU orphan drug designation
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.
Strategic problem-solving for a complex Canadian New Drug Submission
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
Canada for a respiratory drug for chronic obstructive pulmonary disease
Meeting new REMS SPL guidelines 22 months before they became mandatory
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.
Enabling US and EU market entry for neurodegenerative disease treatment
An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. ICON Regulatory Consulting was engaged to support market entry.
Regulatory problem-solving secures crucial extensions in pediatrics and rare disease
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.
Regulatory solutions for uncharted scientific waters
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.
Use of Real World Data to fulfil post-approval requirements
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.
Overcoming time zone and knowledge gaps to gain FDA IND study approval
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.
CMC and local regulatory expertise deliver timely anti-cancer drug approval
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.
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.
Exceeding expectations for late-stage rescue study success
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 Data and System Assessment to ensure IDMP compliance
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.