Regulatory Affairs
Strategic consulting and operational support in a complex environment
ICON’s regulatory teams are leaders in the complex regulatory and product development environment.
We provide support across the entire product development life cycle, from preclinical research through to life cycle maintenance activities. We understand the nuances surrounding global regulatory requirements and development pathways, as well as the factors that may influence the product’s journey from gap analysis through to market approval.
Helping clients navigate complex global regulatory requirements and emerging issues
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35+
Years of consulting experience -
1000+
Regulatory consultants -
300+
Projects -
100+
Countries
Delivering sound regulatory strategies and operational support for drug and device development
Our mission is to deliver customised, end-to-end regulatory solutions with a diverse team of industry recognised consultants who provide best-in-class support to our clients.
ICON’s Regulatory Consulting Solutions team are leaders in the complex regulatory environment, having built their expertise within the biotech and pharma industries.
We provide a full suite of regulatory solutions in key markets globally. Our extensive experience with the FDA, European, PMDA and international regulatory authorities allow us to deliver strategic and operational support to expedite your drug and device development programs across the entire product lifecycle.
Strategic and operational consulting
Deliver regulatory strategic consulting across the product life cycle, offering practical solutions and guidance to expedite product registration.
End-to-end regulatory expertise
Offer end-to-end regulatory services guiding our clients through the complex regulatory landscape and bring safe and compliant products to market.
Strong global presence
Our global reach helps navigate diverse regulatory environments, adapt to local requirements and provide seamless support to clients regardless of location.
Flexible resourcing models
Resources that can be adjusted as needed. Provide customised regulatory support through working models, tailored to meet client requirements.
Your flexible service regulatory partner
Regulatory Consulting Solutions consists of 7 key functions (outlined below), with 50+ service capabilities that can be offered to clients as standalone, or bundled services.
Regulatory Consulting Solutions
- Regulatory Project Services We provide regulatory project management and submission management services with demonstrated success, facilitating delivery of timely and compliant dossiers worldwide.
- Global Regulatory Strategy ICON offers full-service development and regulatory consultancy, providing both strategic and operational support throughout the product development life cycle, covering preclinical/analytical and clinical trial evaluation, marketing authorisation and post-approval maintenance.
- CMC and Quality The ICON Chemistry, Manufacturing & Controls and Quality team provides sound CMC strategies that are executed by industry-leading experts.
- Regulatory Operations ICON provides a full range of regulatory submission publishing services, including document formatting, submission readiness, report-level publishing, eCTD/ NeeS/ paper publishing, quality control, dispatch and archival submissions.
- Global Labelling and Ad Promo ICON global labelling and ad promotion supports all stages of product development, maintenance and operations.
- Regulatory Affairs Medical Devices & IVD Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements, often beyond what is available in published guidance documents and other materials.
- Clinical Trial – Global Regulatory Affairs Our regulatory teams will work with you to create a strategy early in development to identify key challenges that may arise and to interact collaboratively with regulatory authorities.
Regulatory Project Services
We provide regulatory project management and submission management services with demonstrated success, facilitating delivery of timely and compliant dossiers worldwide.
Global Regulatory Strategy
ICON offers full-service development and regulatory consultancy, providing both strategic and operational support throughout the product development life cycle, covering preclinical/analytical and clinical trial evaluation, marketing authorisation and post-approval maintenance.
CMC and Quality
The ICON Chemistry, Manufacturing & Controls and Quality team provides sound CMC strategies that are executed by industry-leading experts.
Regulatory Operations
ICON provides a full range of regulatory submission publishing services, including document formatting, submission readiness, report-level publishing, eCTD/ NeeS/ paper publishing, quality control, dispatch and archival submissions.
Global Labelling and Ad Promo
ICON global labelling and ad promotion supports all stages of product development, maintenance and operations.
Regulatory Affairs Medical Devices & IVD
Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements, often beyond what is available in published guidance documents and other materials.
Clinical Trial – Global Regulatory Affairs
Our regulatory teams will work with you to create a strategy early in development to identify key challenges that may arise and to interact collaboratively with regulatory authorities.
Providing global and local regulatory insights
We continuously monitor today’s complex and ever-changing global regulatory landscape so that we can deliver quality regulatory services and submissions. By staying ahead of current legislation, guidelines and other regulatory intelligence, we can advise you across all aspects of the development process, including the maintenance of marketed products. Our global presence enables us to bring a deep understanding of local regulatory requirements to every project, keeping your research on time and importantly on budget.
To keep abreast of regulatory changes, subscribe to our monthly Global Regulatory Intelligence newsletter.
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Regulatory Intelligence newsletter
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