Catain Labs
Catain Labs offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services for pharmaceutical and biotech companies. They simplify compliance and accelerate approvals.
Catain Labs specializes in guiding pharmaceutical, biotechnology, and healthcare companies through the complex U.S. regulatory landscape, making FDA compliance straightforward, reliable, and efficient. With expertise in IND, NDA, ANDA, NDC, FEI, GDUFA, and eCTD submissions, they provide end-to-end regulatory support tailored to business needs. For foreign companies, Catain Labs serves as the official U.S. Agent, managing all FDA communication, submissions, and compliance requirements seamlessly. They also handle the entire registration and annual renewal process for manufacturing, repacking, or distribution facilities, ensuring continuous compliance. Their services include preparing, formatting, validating, and submitting applications in eCTD format for smooth FDA review, and providing complete support for applying for, assigning, and maintaining National Drug Code (NDC) numbers. Catain Labs acts as a regulatory partner, helping clients minimize risks, reduce delays, and achieve approvals with confidence.
About
**Who they are**
Catain Labs guides pharmaceutical, biotechnology, and healthcare companies through the U.S. regulatory landscape, aiming to make FDA compliance straightforward, reliable, and efficient. They position themselves as a regulatory partner, helping clients minimize risks and reduce delays.
**Expertise & scope**
* Specializes in ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions.
* Offers end-to-end regulatory support tailored to business needs.
* Provides FDA regulatory consulting services.
* Offers eCTD publishing.
* Provides establishment registration.
* Offers National Drug Code (NDC) services.
* Provides US Agent services for foreign manufacturers.
**Reputation / proof points**
* Experienced in guiding companies through complex U.S. regulatory requirements.
Catain Labs guides pharmaceutical, biotechnology, and healthcare companies through the U.S. regulatory landscape, aiming to make FDA compliance straightforward, reliable, and efficient. They position themselves as a regulatory partner, helping clients minimize risks and reduce delays.
**Expertise & scope**
* Specializes in ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions.
* Offers end-to-end regulatory support tailored to business needs.
* Provides FDA regulatory consulting services.
* Offers eCTD publishing.
* Provides establishment registration.
* Offers National Drug Code (NDC) services.
* Provides US Agent services for foreign manufacturers.
**Reputation / proof points**
* Experienced in guiding companies through complex U.S. regulatory requirements.
Additional information
Catain Labs focuses on simplifying the FDA compliance process for pharmaceutical and biotech companies. Their services are designed to accelerate approvals by ensuring submissions are accurate and timely. They handle various submission types, including IND, NDA, ANDA, and DMF, as well as establishment registration and NDC services. For foreign manufacturers, they offer dedicated US Agent services to facilitate compliance with FDA regulations. Their business hours are Monday to Friday, 8:00 AM to 5:00 PM.
Key Highlights
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Provides US Agent services for foreign manufacturers.
Source
“US Agent Services for FDA Compliance”
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Offers expertise in ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions.
Source
“expertise in ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions”
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Provides eCTD publishing and establishment registration services.
Source
“eCTD Publishing Establishment Registration”
Certifications & Trust Signals
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Operating hours are Monday to Friday, 8:00 am to 5:00 pm.
Source
“Monday - Friday 08:00am – 05:00pm”
Buyer Snapshot
Best for
- Pharmaceutical companies seeking FDA regulatory guidance
- Biotechnology firms needing submission support
- Foreign manufacturers requiring a US Agent
How engagement typically works
- Partnership approach
- Tailored regulatory support
Typical deliverables
- FDA regulatory consulting
- eCTD publishing
- Establishment registration
- National Drug Code (NDC) services
- US Agent services
Good to know
- Best when requiring assistance with U.S. FDA regulations for pharmaceutical and biotech products.
HQ:
United States, US
Languages:
English
Timezones:
EST, PST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Annual Renewal Support:
Yes
Registration Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Pharmaceutical, Biotechnology
Registration Support
Yes
Inspection Support
Yes
Emergency Contact24x7
No
