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, making FDA compliance straightforward 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
* Support for startups and established companies managing global portfolios
**Reputation / proof points**
* Acts as a regulatory partner to minimize risks and reduce delays.
Catain Labs is a regulatory consulting firm dedicated to guiding pharmaceutical, biotechnology, and healthcare companies through the U.S. regulatory landscape, making FDA compliance straightforward 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
* Support for startups and established companies managing global portfolios
**Reputation / proof points**
* Acts as a regulatory partner to minimize risks and reduce delays.
Additional information
Catain Labs emphasizes a partnership approach, aiming to be more than just consultants. They focus on ensuring submissions are accurate, compliant, and on time. Their services are designed to help clients achieve approvals with confidence. Business hours are Monday to Friday, 8:00 AM to 5:00 PM.
Key Highlights
-
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.”
-
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.”
-
Provides end-to-end regulatory support tailored to business needs, including ANDA, 505(b)(2), IND, NDC, FEI, and GDUFA submissions.
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
-
Catain Labs aims to make FDA compliance straightforward, reliable, and efficient.
Source
“Our mission is simple: to make FDA compliance straightforward, reliable, and efficient.”
-
Positions themselves as a regulatory partner to minimize risks and reduce delays.
Source
“We pride ourselves on being more than consultants—we’re your regulatory partner, helping you minimize risks, reduce delays, and achieve approvals with confidence.”
Buyer Snapshot
Best for
- Pharmaceutical companies
- Biotechnology companies
- Healthcare companies
- Foreign manufacturers requiring a US Agent
How engagement typically works
- Regulatory partner
- End-to-end regulatory support
Typical deliverables
- FDA Regulatory Consulting Services
- US Agent representation
- eCTD Publishing
- Establishment Registration
- National Drug Code (NDC) services
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
Find 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, Healthcare products
Registration Support
Yes
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare Catain Labs and other vetted providers — instant pricing, no RFQ needed.
