ZUVCHEM provides end-to-end regulatory support for companies operating in or entering the US market. Our services cover facility registrations, product listings, ongoing reporting, and export certifications, keeping manufacturers and distributors compliant across the entire product lifecycle. We work with a practical, business-minded approach, reducing regulatory burden without compromising compliance.
US REGULATORY SERVICES
Compliance Made Simple. Comprehensive U.S. Regulatory Services
Navigating US regulatory requirements demands precision and deep expertise. ZUVCHEM delivers expert regulatory services built on structured processes and close client collaboration, ensuring accuracy, timely execution, and full alignment with the requirements of the FDA, USDA, EPA, and other applicable US regulatory authorities, from initial submission through approval.
The result: faster market entry and successful commercialization.
Enabling Market Entry & Growth
Enabling Market Entry & Growth
ZUVCHEM provides end-to-end regulatory support for companies operating in or entering the U.S. market.
Our services cover facility registrations, product listings, ongoing reporting and export certifications, helping manufacturers and distributors remain compliant throughout the entire product lifecycle.
All services are delivered with a practical, business-oriented mindset, reducing regulatory burden while maintaining the highest compliance standards.
US Regulatory Services Overview
US FDA Facility Registration & FEI Assignment
DUNS
Registration
Prior Notice System Interface (PNSI)
US FDA Food Facility Registration
National Drug Code (NDC) / Labeler Code Request & Assignment
Drug Listing and Certification
IOR (Importer of Record) Setup & Maintenance
Outsourcing Facility Registration (503B)
Compounded Drug Product Reporting
DSCSA Annual Reporting (Drug Distributors & 3PLs)
Generic Drug Self-Identification (GDUFA)
Cosmetic Facility Registration & Product Listing (MoCRA Compliance)
CDER Export Certification (CDER eCATS)
CVM Export Certification (CVM eCATS)
U.S. Regulatory FAQ
What are U.S. regulatory services?
U.S. regulatory services include FDA registrations, product listings, reporting obligations and compliance activities required to legally market pharmaceutical, nutraceutical and related products in the United States.
Does ZUVCHEM support foreign companies entering the U.S. market?
Yes. ZUVCHEM specializes in supporting international manufacturers with structured regulatory services to facilitate U.S. market entry and ongoing compliance.
Can multiple regulatory services be managed together?
Yes. Our approach integrates registrations, listings and reporting activities to reduce complexity and ensure consistency across regulatory requirements.
CONTACT US
Let’s Discuss Your Regulatory Requirements
Whether you are preparing for market entry, evaluating regulatory pathways, or seeking support with FDA compliance, our team is here to help. Submit your inquiry below, and we’ll provide tailored guidance based on your product, development stage, and regulatory objectives.