Regulatory Intelligence

US Agent Requirements for Foreign Establishments

Understand when you need a US Agent, what responsibilities they have, and how to select the right agent for your FDA-regulated business.

10 min read•Beginner

FDA Inspection Preparation Guide

Be ready when FDA inspectors arrive. Learn what to expect, how to prepare your facility, employee training, and post-inspection best practices.

17 min read•Intermediate

Prior Notice Filing for Food Imports

File Prior Notice correctly every time. Timing requirements, data elements, common errors, and tips for high-volume importers.

12 min read•Beginner

Drugs

NDC Numbers: Complete Registration Guide

Everything about National Drug Codes - structure, registration process, labeler codes, and maintaining your NDC directory listings.

13 min read•Intermediate

Drugs

Drug Establishment Registration Guide

Register your pharmaceutical facility with the FDA. Annual registration requirements, drug listing, fees, and compliance timelines.

15 min read•Intermediate

cGMP for Food Manufacturing: Complete Guide

Understand Current Good Manufacturing Practice requirements for food facilities. Covers 21 CFR Part 117, sanitation, personnel, and documentation.

18 min read•Intermediate

FSVP Importer Requirements: Complete Guide

Everything importers need to know about the Foreign Supplier Verification Program — supplier evaluation, hazard analysis, corrective actions, and recordkeeping.

20 min read•Advanced

Prior Notice Filing: Complete Guide

Comprehensive guide to FDA prior notice requirements for imported food. Filing timelines, data elements, common rejection reasons, and best practices.

16 min read•Intermediate

MoCRA Adverse Event Reporting Guide

Navigate mandatory adverse event reporting under MoCRA. 15-day reporting requirements, serious AE definitions, FDA Form 3500A, and recordkeeping obligations.

14 min read•Intermediate

FDA Soap vs Cosmetic Classification Guide

Classify soap products correctly under FDA rules. Learn how claims and intended use shift products into cosmetic or drug pathways.

9 min read•Beginner

Cosmetic Shelf-Life and Expiration Dating Guide

Build a practical shelf-life and expiration dating policy for cosmetics with label, claim, and evidence controls.

10 min read•Intermediate

Cosmetics Importers and Exporters Guide

Operational controls for cosmetic imports into the U.S., including data readiness, monitoring, and response workflows.

11 min read•Intermediate

FDA Import Offices and Ports of Entry Guide

How to align prior notice, FSVP, and import communication workflows with FDA port and office handling.

10 min read•Intermediate

PMA Premarket Approval Guide

Navigate the FDA Premarket Approval process for Class III medical devices. Application requirements, clinical data, review timelines, and post-approval obligations.

22 min read•Advanced

UDI System Guide: Unique Device Identification

Complete guide to the FDA Unique Device Identification system. UDI formatting, GUDID submission, labeling requirements, and compliance deadlines by device class.

17 min read•Intermediate

FSMA Compliance: The Complete Guide

Everything you need to know about the Food Safety Modernization Act — all 7 final rules, compliance deadlines, exemptions, and how to build a compliant food safety system.

20 min read•Intermediate

HARPC Plan: The Complete Guide

Build a compliant Hazard Analysis and Risk-Based Preventive Controls plan. HARPC vs HACCP, the 14-step process, and 21 CFR 117 requirements.

16 min read•Intermediate

FDA Warning Letter Response: The Complete Guide

Received an FDA warning letter? Learn the 15-day response timeline, how to write an effective response, common violations by industry, and prevention strategies.

18 min read•Advanced

US Agent for Foreign Facilities: The Complete Guide

Everything foreign facilities need to know about FDA US Agent requirements — legal obligations, cost comparison, how to choose an agent, and country-specific guidance.

14 min read•Beginner

FDA Import Compliance: The Complete Guide

Navigate importing FDA-regulated products into the US — Prior Notice, FSVP, import alerts, labeling, CBP coordination, and country-specific requirements.

22 min read•Advanced

PCQI Training: The Complete Guide

Everything about becoming a Preventive Controls Qualified Individual — FSPCA training curriculum, online vs in-person options, responsibilities, and maintaining qualification.

14 min read•Beginner

FDA UDI Compliance: The Complete Guide

Navigate the Unique Device Identification system — device identifiers, production identifiers, GUDID submissions, label marking rules, and compliance deadlines.

16 min read•Intermediate

FDA Nutritional Labeling: The Complete Guide

Master FDA nutrition labeling requirements — Nutrition Facts panel, serving sizes, allergen declarations, front-of-package rules, and common labeling violations.

18 min read•Intermediate