- Home
- >
- United States
- >
- Regulatory Affairs
Regulatory Affairs Consulting Services in the United States

Services We Offer
Regulatory Affairs Services in United States
Regulatory Authority | Industry 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
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.
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.
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.
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-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.
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?




FAQs
1. Is it mandatory to engage with the FDA for every product type in the U.S.?
2. What’s the most common reason for delays in U.S. regulatory approvals?
3. Can Artixio support pre-submission meetings with the FDA?
4. How does Artixio help companies expanding from outside the U.S.?
Still Have Questions ?
Industries We Serve in the USA
Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy

Medical & Technical Writing

Publishing & Submission






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

IVD Medical Devices Registration
The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...

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