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.

Services We Offer

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 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

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.?

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.

2. What’s the most common reason for delays in U.S. regulatory approvals?

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.

3. Can Artixio support pre-submission meetings with the FDA?

Yes. We help prepare for pre-submissions, including Q-Subs, Type C meetings, and informal communications, so you enter discussions with clarity and strategy.

4. How does Artixio help companies expanding from outside the U.S.?

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.