ICON plc
★★★★★
3.1
/ 5
•
18 reviews
ICON plc – Expert FDA 510(k) & Medical Device Regulatory Consulting
ICON plc's medical device & IVD regulatory experts offer a deep understanding of applicable regulations and requirements, extending beyond published guidance to help clients navigate complex global landscapes. They specialize in ensuring compliance and facilitating market access for a wide range of medical technologies.
About
**Who they are**
ICON plc is a global provider of consulting and commercial services, with a significant focus on regulatory affairs for drug and device development.
**Expertise & scope**
* Expertise in navigating complex global regulatory requirements and emerging issues.
* Support for clinical trial submissions, strategic development, licensing (MAA/BLA/NDA), and lifecycle management.
* Offers regulatory project management and submission management services for worldwide dossier delivery.
* Provides regulatory intelligence, including insights on FDA guidance, AI in SaMD, and risk management for medical devices.
**Reputation / proof points**
* Over 1000 regulatory consultants.
* 35+ years of consulting experience.
* Over 100 locations globally.
* Handles a high volume of submissions annually: 17,000+ total, 10,700+ clinical trial submissions, and 6,350+ strategic development/licensing/lifecycle management submissions.
ICON plc is a global provider of consulting and commercial services, with a significant focus on regulatory affairs for drug and device development.
**Expertise & scope**
* Expertise in navigating complex global regulatory requirements and emerging issues.
* Support for clinical trial submissions, strategic development, licensing (MAA/BLA/NDA), and lifecycle management.
* Offers regulatory project management and submission management services for worldwide dossier delivery.
* Provides regulatory intelligence, including insights on FDA guidance, AI in SaMD, and risk management for medical devices.
**Reputation / proof points**
* Over 1000 regulatory consultants.
* 35+ years of consulting experience.
* Over 100 locations globally.
* Handles a high volume of submissions annually: 17,000+ total, 10,700+ clinical trial submissions, and 6,350+ strategic development/licensing/lifecycle management submissions.
Additional information
ICON plc emphasizes a flexible approach to developing transformative therapies, offering technology solutions from early phase through post-marketing. Their regulatory affairs services are designed to reduce time to market and enhance R&D ROI. They provide deep therapeutic expertise and focus on delivering quality across their full range of services. Buyers should consider ICON's extensive global presence and long history in consulting when evaluating project scope and support needs.
Key Highlights
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Over 35 years of consulting experience in regulatory affairs.
Source
“35+ Years of consulting experience”
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Employs over 1000 regulatory consultants globally.
Source
“1000+ Regulatory consultants”
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Supports over 17,000 total submissions annually.
Source
“17,000+ Total submissions annually*”
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Operates from over 100 global office locations.
Source
“100+ Locations”
Certifications & Trust Signals
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ICON plc has over 35 years of consulting experience.
Source
“35+ Years of consulting experience”
Buyer Snapshot
Best for
- Companies seeking expert guidance on complex global regulatory requirements.
- Organizations needing support with drug and device development submissions.
- Clients requiring strategic regulatory planning and operational execution.
How engagement typically works
- Collaborative approach with regulatory authorities.
- Flexible service partnership.
- Project management for timely dossier delivery.
Typical deliverables
- Regulatory strategies and operational support.
- Clinical trial regulatory plans.
- Worldwide compliant dossiers.
- Insights on regulatory intelligence.
Good to know
- Best when requiring deep therapeutic expertise and technology-driven solutions.
HQ:
Dublin, CA
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
15
Num510k Submitted:
45
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd
Accepting New Clients:
Yes
