Artixio

Regulatory Affairs Consulting Services in the United States

Artixio helps you meet U.S. regulatory standards in life sciences. From approval to market launch, we support your product’s journey with expertise.

Regulatory Affairs Services in United States

At Artixio, we understand the nuances of U.S. regulatory affairs and the demands of the FDA approval process. Our team of experts works closely with you to help your product meet the required standards for market entry. Whether it’s pharmaceuticals, medical devices, or biologics, we support you through every step—from pre-market assessments to post-market surveillance—ensuring compliance at each stage. By simplifying the process and providing clear insights, we help you avoid delays and focus on your market goals while ensuring full compliance with U.S. standards.
Regulatory AuthorityIndustry Focus
FDA (Food and Drug Administration)Pharmaceuticals, Biologics, Medical Devices, Cosmetics, Nutrition
DEA (Drug Enforcement Administration)Pharmaceuticals (Controlled Substances)
EPA (Environmental Protection Agency)Cosmetics, Nutrition, Pharmaceuticals (Environmental Impact)
FTC (Federal Trade Commission)Cosmetics, Nutrition
CDER (Center for Drug Evaluation and Research)Pharmaceuticals
CVM (Center for Veterinary Medicine)Veterinary Products

Regulatory Affairs Lifecycle in the United States

Product Strategy and Regulatory Pathway Selection

At Artixio, we start by understanding your product and defining the best regulatory path based on FDA requirements. This is the first step toward aligning your product with U.S. market needs.

Submission Preparation

Once the path is clear, we assist in preparing all the necessary documentation for your FDA application—whether it's for a New Drug Application (NDA), Biologics License Application (BLA), or 510(k) for devices.

FDA Review Process

After submission, the FDA will review your application. We support you by addressing any questions, providing additional data, or clarifying points to ensure smooth communication with the FDA.

Approval and Compliance

Once approved, we work with you to ensure your product is in full compliance with U.S. regulations—whether that’s for marketing, labeling, or ongoing safety requirements.

Post-Market Surveillance and Monitoring

Post-launch, we monitor the product’s performance in the U.S. market. This includes tracking adverse events and assisting in necessary reporting to the FDA, ensuring continuous compliance.

Ongoing Regulatory Support

Compliance doesn’t end at launch. Artixio remains a trusted partner, ensuring your product meets all U.S. regulatory updates and supports any required renewals, modifications, or reports.

Why Choose Artixio for U.S. Regulatory Affairs?

15 to 30+ years of experience managing FDA processes for diverse product categories.
Successfully managed over 100 FDA submissions across multiple life sciences industries.
Proven track record with more than 500 FDA approvals and registrations across various sectors.
We focus on your goals, ensuring that every decision aligns with your business priorities.

FAQs

1. Is it mandatory to engage with the FDA for every product type in the U.S.?
Not always. Some products may qualify for exemption or follow alternate routes like 510(k) or OTC monographs. But for most regulated categories, interaction with the FDA is expected at some stage — we help identify the right path early on.
Incomplete data, inconsistent documentation, or misaligned submission formats often cause hold-ups. That’s where our review and submission expertise comes in — spotting gaps before they become setbacks.
Yes. We help prepare for pre-submissions, including Q-Subs, Type C meetings, and informal communications, so you enter discussions with clarity and strategy.
We translate foreign product data into FDA-acceptable formats, advise on labeling, adapt dossiers to U.S. standards, and handle communications with the FDA on your behalf.

Still Have Questions ?

Get expert answers tailored to your needs.

Industries We Serve in the USA

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

Insights from Artixio - Tips & Articles

In Vitro Diagnostics: Meaning, Types And Benefits

In Vitro Diagnostics: Meaning,

The term “in vitro” is a Latin word that means “in glass”. Thus, from...

June 20, 2025
IVD Medical Devices Registration & Approval In India

IVD Medical Devices Registration

The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...

June 17, 2025
Pharma Manufacturing Booms in Hidalgo, Mexico

Pharma Manufacturing Booms in

Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with global market...

June 18, 2025