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, seamlessly handling FDA communication, submissions, and compliance requirements. They also manage the entire registration and annual renewal process for manufacturing, repacking, or distribution facilities, and provide complete support for applying for, assigning, and maintaining National Drug Code (NDC) numbers. Their services include preparing, formatting, validating, and submitting applications in eCTD format to ensure smooth FDA review. Catain Labs acts as a regulatory partner, helping clients minimize risks, reduce delays, and achieve approvals with confidence.
About
**Who they are**
Catain Labs is a regulatory consulting firm dedicated to guiding pharmaceutical, biotechnology, and healthcare companies through the U.S. regulatory landscape. Their mission is to make FDA compliance straightforward, reliable, and efficient.
**Expertise & scope**
* FDA Regulatory Consulting Services
* US Agent services
* eCTD Publishing
* Establishment Registration
* National Drug Code (NDC) submissions
* Expertise in ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions
**Reputation / proof points**
* Years of expertise in various FDA submission types.
Catain Labs is a regulatory consulting firm dedicated to guiding pharmaceutical, biotechnology, and healthcare companies through the U.S. regulatory landscape. Their mission is to make FDA compliance straightforward, reliable, and efficient.
**Expertise & scope**
* FDA Regulatory Consulting Services
* US Agent services
* eCTD Publishing
* Establishment Registration
* National Drug Code (NDC) submissions
* Expertise in ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions
**Reputation / proof points**
* Years of expertise in various FDA submission types.
Additional information
Catain Labs positions itself as a regulatory partner, aiming to minimize risks and reduce delays for clients seeking FDA approvals. They offer end-to-end regulatory support, tailored to the specific needs of businesses ranging from startups to established companies managing global portfolios. Their services are designed to ensure submissions are accurate, compliant, and on time.
Key Highlights
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Specializes in guiding pharmaceutical, biotechnology, and healthcare companies through the U.S. regulatory landscape.
Source
“At Catain, we specialize in guiding pharmaceutical, biotechnology, and healthcare companies through the complex U.S. regulatory landscape.”
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Offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services.
Source
“Services FDA Regulatory Consulting Services US Agent eCTD Publishing Establishment Registration National Drug Code (NDC)”
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Provides end-to-end regulatory support for various submission types including ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA.
Source
“With years of expertise in ANDA, 505(b)(2), IND, NDC, FEI, GDUFA, and eCTD submissions, we provide end-to-end regulatory support tailored to your business needs.”
Certifications & Trust Signals
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Operates Monday - Friday from 08:00 am to 05:00 pm.
Source
“Monday - Friday 08:00am – 05:00pm”
Buyer Snapshot
Best for
- Companies seeking FDA regulatory consulting
- Pharmaceutical and biotech firms needing US Agent services
- Businesses requiring eCTD publishing and establishment registration
How engagement typically works
- Regulatory partnership
- Tailored support for business needs
Typical deliverables
- FDA submission guidance
- US Agent representation
- eCTD publishing
- Establishment registration
- National Drug Code (NDC) services
Good to know
- Best when requiring specialized FDA regulatory support in the US.
HQ:
New Jersey, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, Drugs, Foods
Portfolio:
6-25, 26-100, 100+
Onboarding time:
2–5 days
Pricing model:
Retainer
Starting from:
USD 1,500
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Inspection coordination, NDC registration support, eCTD publishing services
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, and healthcare products.
Registration Support
Yes, Establishment Registration is offered.
