Artixio
Artixio offers scalable regulatory consulting solutions for the entire product lifecycle, powered by AI. They provide global regulatory expertise and insourcing models to support critical needs in the life sciences industry.
Artixio provides comprehensive regulatory consulting services designed to support the entire product lifecycle, from initial concept through launch and post-launch activities. Leveraging AI-enabled platforms, their flexible business models facilitate global scaling and timely market entry. With a global team of over 250 regulatory experts across 120+ countries, Artixio specializes in New Product Registration, Post Approval Maintenance, Dossier Preparation, Submission, and Health Authority Liaison. Their expertise spans a wide range of products, including pharmaceuticals, medical devices, biologics, veterinary products, and consumer goods, ensuring compliance with Health Authority requirements. Artixio's Insourcing Model is designed to address regional resource gaps with speed, accuracy, and agility. They offer short-, mid-, and long-term contingent staffing solutions to meet critical, time-sensitive needs within the life sciences sector. Their services encompass Regulatory Affairs, Regulatory Intelligence, and Regulatory Operations, including product registration, technical medical writing, lifecycle maintenance, advertising review, artwork labeling, publishing submissions, and legal representation.
About
**Who they are**
Artixio is a global consulting and services company specializing in regulatory and compliance support for the life sciences industry. They offer AI-powered regulatory consulting solutions designed to cover the entire product lifecycle.
**Expertise & scope**
* Global regulatory expertise and insourcing models
* Support for product registration through post-market compliance across 120+ countries
* Regulatory Affairs Services including Product Registration, Technical Medical Writing, Product Lifecycle Maintenance, Advertising Promotional Review, and Regulatory Artwork Labeling
* Regulatory Intelligence Solutions
* AI Consulting and Technology
* Services for Pharmaceuticals, Medtech, Cosmetics, Nutrition, Biologics, and Veterinary industries
**Reputation / proof points**
* Founded in 2019 (implied by timeline on About Us page)
* Global presence with offices in the United States, Germany, Mexico, and India
Artixio is a global consulting and services company specializing in regulatory and compliance support for the life sciences industry. They offer AI-powered regulatory consulting solutions designed to cover the entire product lifecycle.
**Expertise & scope**
* Global regulatory expertise and insourcing models
* Support for product registration through post-market compliance across 120+ countries
* Regulatory Affairs Services including Product Registration, Technical Medical Writing, Product Lifecycle Maintenance, Advertising Promotional Review, and Regulatory Artwork Labeling
* Regulatory Intelligence Solutions
* AI Consulting and Technology
* Services for Pharmaceuticals, Medtech, Cosmetics, Nutrition, Biologics, and Veterinary industries
**Reputation / proof points**
* Founded in 2019 (implied by timeline on About Us page)
* Global presence with offices in the United States, Germany, Mexico, and India
Additional information
Artixio emphasizes a client-friendly environment, providing care and attention to projects of any size. Their team is committed to quick responses and attention to detail, from initial contact through ongoing project management. They aim to ensure a smooth product journey from concept to market and beyond, leveraging a blend of domain expertise, legal, marketing, and business acumen.
Key Highlights
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Offers AI-powered regulatory consulting solutions for the entire product lifecycle.
Source
“Artixio offers scalable regulatory consulting solutions for the entire product lifecycle, powered by AI.”
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Supports life sciences companies in over 120 countries.
Source
“Supporting Life Sciences companies across 120+ countries — from product registration to post-market compliance, we handle the tough regulatory work so you don’t have to.”
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Provides a comprehensive suite of Regulatory Affairs Services.
Source
“Regulatory Affairs Services Product Registration Services Technical Medical Writing Product Lifecycle Maintenance Advertising Promotional Review Regulatory Artwork Labeling”
Certifications & Trust Signals
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Global presence with offices in the United States, Germany, Mexico, and India.
Source
“United States; Germany; Mexico; India South; India North”
Buyer Snapshot
Best for
- Life sciences companies needing global regulatory compliance support.
- Organizations seeking AI-powered solutions for regulatory challenges.
How engagement typically works
- Responsive and detail-oriented project management.
- Insourcing models for critical needs.
Typical deliverables
- Regulatory strategy and intelligence.
- Product registration and lifecycle maintenance.
- Technical medical writing.
- Promotional review and artwork labeling.
Good to know
- Best when requiring support across multiple global markets.
HQ:
US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Registration Support:
Yes
Product Type:
devices
Additional us_agent_fda Details
Product Types
Pharmaceuticals, Medtech, Cosmetics, Nutrition, Biologics, Veterinary
Registration Support
Yes
