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Artixio

United States

USA Regulatory Affairs and Compliance Partner

Strategy to Product Launch and Post Market, Ensuring Compliance Through the Lifesciences Products Lifecycle

Regulatory Compliance Company in the USA

The United States of America is key markets for global manufacturers and brands across industries. The massive Pharmaceutical, Medical Devices, Nutraceutical and Cosmetics industry with market size of approx. USD 600 Billion, 300 Billion, 85 Billion and 67 Billion respectively, enables lifesaving, health and wellness innovations to thrive in the country while benefitting end users. With a highly regulated industry led by the Food and Drug Administration (US FDA), every product must go through a stringent evaluation pathway to ensure efficacy and safety of the products for human and animal use.

Artixio, with its team’s decades of experience in successfully registering and post market compliance maintenance for diverse lifesciences products across regulatory affairs, quality (GxP), market access in the USA.

Regulatory Authorities in the USA

Key bodies within FDA that regulate various lifesciences products include, Center for Devices and Radiological Health (CDRH) that Regulates companies that manufacture, import or market medical devices in the USA; Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) that is responsible for review and regulation of biopharmaceutical products; Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine

Pre-Registration

Registration services

Post-Registration

Our Regulatory Services in the USA

Regulatory advisory consultant – Artixio
Regulatory Affairs
Product Registration Services Artixio
Product Registration
Global regulatory advisory services – Artixio
Market Access
Compliance and regulatory consulting – Artixio
Regulatory compliance consulting services
IND (Investigational New Drug)
Compliance and regulatory consulting – Artixio
New Drug Application Regulatory
NDA (New Drug Application)
Compliance and regulatory consulting – Artixio
Regulatory operations consulting services Artixio
Regulatory Operations
Compliance and regulatory consulting – Artixio
Technical Writing in Regulatory Artixio
Technical Writing
Regulatory Strategy Services Artixio
Regulatory Strategy
Life sciences consulting services Artixio
Market Access

Why Artixio for FDA Regulatory Compliance Services in the USA?

Compliance consulting services company
Successful Approvals and Ongoing Product Lifecycle Maintenance for 200+ Products
Compliance consulting services company
Diverse Experience across Complex Products Categories and Therapeutic Areas
Compliance consulting services company
Strong Regional Expertise, Experts with 15-35 years of experience
Compliance consulting services company
End-to-End Partner Concept to Market & Post Market
Compliance consulting services company
Proven Experience in Navigating through Complex, often Ambiguous Regulations
Compliance consulting services company
Intelligence driven, global regulatory services supported by QuriousRI
Compliance consulting services company
ISO 9001:2015 quality standards governed services.
Compliance consulting services company
Customer focused, flexible services and solutions.
Compliance consulting services company
Flexible Business Model including project based, managed services and FTE staffing model.
Compliance consulting services company
Hybrid-Local-Centralized Support across Regulatory functions.

Industries We Serve in the USA

Regulatory and compliance expert – Artixio

Pharmaceuticals

Medical device regulatory services – Artixio

MedTech

Cosmetics regulatory consulting – Artixio

Cosmetics

Nutrition regulatory consulting – Artixio

Nutrition

Biologics regulatory consulting – Artixio

Biologics

Veterinary regulatory consulting – Artixio

Veterinary

FAQs

What are different submissions that you support in the USA?
Artixio supports submissions for products across pharmaceutical, biological, medical devices, diagnostics, cosmetics, nutraceuticals, veterinary, animal feed and related industries. The submissions include IND, NDA, ANDA, BLA, 510(k), PMA, De Novo Requests, NDI notifications, Cosmetic Facility Registrations, MoCRA, INAD, NADA and others.
Yes, Artixio supports international manufacturers by acting as their US Agent representing them to the FDA, managing communication, audit support, response to queries and coordinate submission/post submission activities.
We support post approval maintenance activities such as change/variations management, CMC change management, artwork and labelling change management, advertisement and promotional material review, SPL filing, renewals, annual reports ongoing regulatory intelligence and monitoring.
We support right from Quality Management System (QMS) development, implementation and training, Standard Operating Procedures authoring, harmonization, support with mock audits and vendor audits across GMP, GCP, GPVP, GDP and other areas. Our compliance team is seasoned to guide through 21 CFR Part 210/211, 820, 600, 111, ISO 13485, 22716 for different product types.

Our Global Reach: Serving Life
Sciences Clients Worldwide

India Artixio – Regulatory affairs consulting expert

India

Singapore Artixio – Regulatory affairs consulting expert

Singapore

Mexico Artixio – Regulatory affairs consulting expert

Mexico

Brazil Artixio – Regulatory affairs consulting expert

Brazil

Vietnam Artixio – Regulatory affairs consulting expert

Vietnam

Malaysia Artixio – Regulatory affairs consulting expert

Malaysia

Argentina Artixio – Regulatory affairs consulting expert

Argentina

Colombia Artixio – Regulatory affairs consulting expert

Colombia

Taiwan Artixio – Regulatory affairs consulting expert

Taiwan

China Artixio – Regulatory affairs consulting expert

China

Europe Artixio – Regulatory affairs consulting expert

Europe

Thailand Artixio – Regulatory affairs consulting expert

Thailand

Indonesia Artixio – Regulatory affairs consulting expert

Indonesia

Philippines Artixio – Regulatory affairs consulting expert

Philippines

USA Artixio – Regulatory affairs consulting expert

USA

Japan Artixio – Regulatory affairs consulting expert

Japan

Qatar

South Korea

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