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 -
900+
Projects -
100+
Locations
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 Affairs teams 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
Provide customised regulatory support through working models such as in-house placement or consulting hours, tailored to meet client requirements.
Your flexible service regulatory partner
Regulatory Affairs consists of a range of functions (outlined below), with 50+ service capabilities that can be offered to clients as standalone, or bundled services.
Regulatory Affairs service offering
- 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 Trials Global Regulatory Our regulatory teams will work with you to create a strategy as part of study start up, to identify key challenges that may arise and to interact collaboratively with regulatory authorities.
- Clinical Diagnostics Regulatory Affairs: IVD/CDx Providing full IVD regulatory affairs and device controls for ICON Laboratories
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 Trials Global Regulatory
Our regulatory teams will work with you to create a strategy as part of study start up, to identify key challenges that may arise and to interact collaboratively with regulatory authorities.
Clinical Diagnostics Regulatory Affairs: IVD/CDx
Providing full IVD regulatory affairs and device controls for ICON Laboratories
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.
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Demystifying EU CTR, MDR and IVDR
In this whitepaper learn about the EU regulation process for medical devices, in vitro diagnostic devices and combined studies and a blueprint for navigating them effectively.
Procedural and regulatory know-how for China biotechs in the EU
ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA.
EMA guideline on computerised systems and electronic data in clinical trials
This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.
Regulatory considerations for biotech
The importance of regulatory affairs when developing an asset and considering a drug development partner.