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**
* Catain Labs acts as a regulatory partner, aiming to minimize risks, reduce delays, and achieve approvals with confidence.
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**
* Catain Labs acts as a regulatory partner, aiming to minimize risks, reduce delays, and achieve approvals with confidence.
Additional information
Catain Labs offers end-to-end regulatory support tailored to client needs, whether for startups or established companies managing global portfolios. They emphasize ensuring that every submission is accurate, compliant, and on time. Their services are designed to simplify the complexities of FDA compliance and accelerate the approval process for pharmaceutical and biotech products.
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 U.S. regulatory landscape.”
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Provides end-to-end regulatory support for various submissions 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.”
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Offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services.
Source
“Catain Labs offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services for pharmaceutical and biotech companies.”
Certifications & Trust Signals
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Business hours are Monday - Friday, 08:00am – 05:00pm.
Source
“Monday - Friday 08:00am – 05:00pm”
Buyer Snapshot
Best for
- Pharmaceutical companies
- Biotechnology companies
- Healthcare companies
How engagement typically works
- Regulatory partner
- End-to-end support
Typical deliverables
- FDA Regulatory Consulting
- US Agent Services
- eCTD Publishing
- Establishment Registration
- National Drug Code (NDC)
Good to know
- Best when seeking to simplify FDA compliance and accelerate approvals.
HQ:
New Jersey, US
Languages:
English
Timezones:
America/New_York
Claim 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, food, drugs
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
Pharmaceuticals, Biotechnology products
Registration Support
Yes
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