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Pharmaceutical Consulting Services in USA
Pharmaceutical consulting company in the United States offering regulatory strategy, submissions, and compliance support for drug products.
Pharmaceuticals
End-to-End Regulatory Support
for Pharmaceutical Products in USA
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
Digital Marketing
Market Access
Regulatory Operations
Pharmaceutical Services for Global Regulatory Compliance
- Regulatory Affairs
- Product Registration Affairs
- Pharmacovigilance
- Digital Marketing
- Post-Marketing Surveillance
- Regulatory Intelligence
- Regulatory Strategy
- Regulatory Operations
- Artwork & Labeling
- Publishing & Submission Services
- Legal Representative
- HA Liaison (Health Authority Liaison)
- Quality Services
- Market Access
- Regulatory Testing
- Regulatory Staffing
- Global Regulatory Outsourcing
-
Performance Evaluation Reports (IVD
Medical Devices) - Active Safety Surveillance
- MDR Gap Assessment
- GMP and Regulatory Compliance
- GxP Compliance & Regulations
- Market Research
- Product Lifecycle Maintenance Services
- Advertisement and Promotional Material Review
- IND (Investigational New Drug)
We’re not the kind of pharma consulting services firm in USA that disappears after sending over a checklist. Once we’re involved, we stay hands-on—tracking progress, spotting issues early, and helping fix things when they go off track. A lot of the real work happens between submissions: following up with the FDA, clarifying feedback, double-checking documents. That’s where our team stays present, and that’s where we often make the biggest difference.
FAQS About Pharma Regulatory in USA
1. We’re planning to file with the FDA. Can you guide us through the process?
Yes. We can step in early—before anything is submitted—and help you figure out what’s required, what’s missing, and what needs to be in place. We also help with timelines, meeting prep, and responding to feedback from the FDA.
2. Do you handle formatting and submission in eCTD?
Yes, we do. Whether it’s a full IND or a supplement, we organize the content, check for gaps, and publish in eCTD format. We also help with submission through ESG and make sure everything’s validated properly.
3. We’re based outside the U.S. Can you still help with FDA submissions?
Absolutely. We work with many non-U.S. clients. If you need a U.S. agent or support understanding what the FDA will expect from your data or documents, we can walk you through it.
4. Can you help us respond to an FDA query or deficiency letter?
Yes. If you’ve received feedback from the FDA and aren’t sure how to respond—or need help putting together the right documents—we can step in quickly and work with your team to prepare a clear and accurate response.
5. Do you only support new applications, or can you help with existing products too?
We support both. Some clients come to us after approval when they need help managing variations, safety updates, or labeling changes. Others reach out mid-process when they hit a roadblock.
Why Choose Artixio?
Expertise in 120+ countries
We respond quickly and don’t keep you waiting
You’ll always know what’s happening and what’s needed next.
We understand how the FDA works—and where issues often pop up.
No copy-paste strategies; we tailor everything to your product and situation.
Regulatory Expertise Across
Multiple Countries
United States
Brazil
European Union
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