Regulatory affairs case studies
Delivering strategic regulatory advisory services 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.
Multilingual global label monitoring for late-stage oncology
By combining global labelling expertise, translation capabilities and adaptable document comparison workflows,
ICON delivered a reliable monitoring program that identified 100 label changes across 500 labels in four languages.
ICON delivered a reliable monitoring program that identified 100 label changes across 500 labels in four languages.
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Rapidly mobilised global labelling review supports oncology portfolio expansion
ICON Global Regulatory delivered a comprehensive label assessments and action plans, ensuring alignment between health authority, core, and local labelling requirements, resulting in a compliant global product portfolio and a contract extension for a second product.
From Shanghai to Singapore: Strategic insights enable a biotech’s APAC expansion
The HSA operates reliance-based evaluation routes for products approved by recognised reference agencies, such as the FDA, EMA, TGA, Swissmedic, Health Canada, and MHRA. However, China’s NMPA is not currently among HSA’s reference agencies
Custom, scalable data automation tool cuts validation timelines by 90%
ICON developed a custom automation tool to cross-check regulatory publishing data for a top 10 global pharmaceutical company managing over 800 monthly requests. The solution reduced verification time by 90%, improving data accuracy and operational efficiency.
Saving a lean biotech more than $4 million with strategic regulatory support
A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.
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.
Custom framework for consistent, compliant global labelling
A global pharmaceutical organisation sought ICON’s help to design an end-to-end regulatory labelling process for their growing organisation.
Creating a roadmap for growth for a blood products company
A top 20 pharma subsidiary scaling plasma-derived therapies asked ICON to review their processes and plan for growth. With plasma reliant on donations, new centers were opening to meet demand and ensure patient access to life-saving treatments.
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
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.