Regulatory Services
From INDs to NDAs and ANDAs, Catain offers strategic regulatory guidance throughout the drug development lifecycle. We help you prepare submissions, manage FDA interactions, and maintain compliance with U.S. regulatory standards.
The services we offer
Electronic Common Technical Document (eCTD) Publishing Services
Our publishing specialists prepare, format, validate, and submit your applications in eCTD format—ensuring smooth FDA review and reducing risk of rejection.
US Agent Services
For foreign companies, we serve as your official U.S. Agent, handling FDA communication, submissions, and compliance requirements seamlessly.
Drug Establishment Registration and Renewal Services
Catain manages the entire registration and annual renewal process for your manufacturing, repacking, or distribution facility with the FDA, keeping you compliant year after year.
National Drug Code (NDC) Services
We provide complete support in applying for, assigning, and maintaining NDC numbers, so your products are properly listed and ready for distribution in the U.S. market.
Drug Listing Services
We prepare and submit accurate product listings to the FDA, ensuring your drug products are properly cataloged and compliant with U.S. regulations.
FDA Establishment Identifier (FEI) Services
We assist companies in obtaining and maintaining their FDA Establishment Identifier (FEI), ensuring accurate facility registration and compliance with FDA requirements.
GDUFA Self Identification Services
Our team helps manufacturers and facilities complete GDUFA self-identification filings correctly and on time, avoiding costly delays in generic drug submissions.
Why Choose Us
✅ Deep expertise in FDA regulatory pathways
✅ Fast, accurate, and compliant submissions
✅ Personalized support tailored to your company’s needs
✅ Experience with pharma, biotech, and global clients
