Registration Operations Hub
Coverage for filing workflows, fee planning, and recurring registration execution.
Cosmetics Direct Portal Registration Walkthrough
Step-by-step Cosmetics Direct portal walkthrough for MoCRA facility registration and product listing.
FDA User Fee Programs Explained: PDUFA, MDUFA, GDUFA
PDUFA, MDUFA, and GDUFA user fee programs explained for drug and device sponsors.
FDA Food Facility Unique Identifier (UFI) Guide
UFI/DUNS identifier requirement for food facility registration.
Annual FDA Registration Renewal SOP: A Practical Operating Model
Build a repeatable renewal SOP with ownership, checkpoints, and quality controls across FDA registration modules.
Food Facility Renewal Data Checklist: What to Validate Before Filing
A data-quality checklist for food facility renewal filings to prevent submission defects and last-minute corrections.
How to Fix a Lapsed FDA Registration: Recovery and Risk Control
Step-by-step process to recover from lapsed FDA registration status and reduce shipment or enforcement exposure.
FDA Registration Renewal Internal Audit: Controls and Scorecards
Run an internal renewal audit to identify control gaps before filing windows and improve on-time submission quality.
Multi-Facility Renewal Governance for FDA Registrations
A governance model for multi-site organizations managing FDA renewals across regions, products, and filing modules.
FDA Registration Fees 2026: Complete Cost Breakdown
Verified FY2026 FDA user fees for devices ($11,423 establishment), drugs ($259,429 PDUFA), and more. Plus Assurentry service fees comparison.
How to Switch Your FDA US Agent: Complete Guide
Step-by-step process for changing your FDA US Agent across food, drug, device, and cosmetics categories. Avoid coverage gaps.
A Complete Guide to Medical Device FDA Registration in 2026
Step-by-step guide to FDA medical device registration: device classification, establishment registration, 510(k) submissions, QSR requirements, and UDI compliance for domestic and foreign manufacturers.
How to Change Your FDA US Agent: Complete Process Guide
Everything you need to know about switching your FDA US Agent: when to change, the step-by-step process, common mistakes to avoid, and how to ensure zero downtime during the transition.
FDA Requirements for Pet Food Manufacturers: What You Need to Know
Pet food is FDA-regulated just like human food. Learn about facility registration, labeling rules, cGMP requirements, FSMA compliance, and import requirements for pet food, animal feed, and pet treats.
The Complete Guide to FDA US Agent Services in 2026
Everything you need to know about FDA US Agent services: what they do, who needs one, how much they cost, and how to choose the right provider for your business.
FDA Registration Costs in 2026: Complete Breakdown
A transparent look at all FDA registration fees including PDUFA, MDUFA, facility registration, and how Assurentry pricing compares to competitors and direct FDA filing.
Who Needs an FDA U.S. Agent? Complete Guide for Foreign Facilities
Every foreign facility that manufactures, processes, packs, or holds food, drugs, devices, or cosmetics for U.S. export must designate a U.S. Agent. Learn who qualifies and how to comply.
How to Change Your FDA U.S. Agent: Step-by-Step Process
Switching your FDA U.S. Agent doesn't have to be complicated. Follow this step-by-step guide covering every product category to change agents without coverage gaps.
MoCRA vs VCRP: What Changed and What You Need to Do Now
The old Voluntary Cosmetic Registration Program (VCRP) is gone. MoCRA replaced it with mandatory requirements. Learn exactly what changed and your new obligations.
FDA Food Facility Registration: 2026 Biennial Renewal Guide
The 2026 biennial renewal window for FDA food facility registration runs Oct 1–Dec 31. Get the full guide on requirements, the renewal process, and how to avoid lapses.
FDA Registration Renewal Calendar: Every Deadline by Product Type
FDA registration renewal deadlines vary by product type. Use this calendar to track food facility biennial renewals, device annual registrations, drug establishment renewals, and MoCRA deadlines.
DUNS Number vs FEI Number: What They Are and When You Need Each
DUNS numbers and FEI numbers are both used in FDA registration but serve different purposes. Learn what each is, how to get them, and which registrations require which.
Dietary Supplement Facility Registration with FDA: Complete Guide
Dietary supplement facilities must register with FDA under 21 CFR Part 207/Part 225. Learn the registration process, GMP requirements, and how foreign manufacturers can comply.
Cosmetics Direct: How to Use FDA's New Submission Portal
Cosmetics Direct is FDA's new SPL-based portal for MoCRA facility registration and product listing. Learn account setup, submission steps, and how to avoid common errors.
OTC Drug Monograph Registration: What Manufacturers Need to Know
OTC drugs marketed under an FDA monograph don't require NDA approval, but the establishment must still register and list products. Learn about the monograph system, MRA reform, and Drug Facts labeling.
How to Get an FDA Labeler Code for Drug Products
An FDA labeler code is the first segment of every NDC number. Learn the step-by-step process to obtain one, including DUNS requirements, SPL submission, and how it links to drug listing.
Import Alert 99-41: What It Means for Foreign Food Facilities
Import Alert 99-41 targets food from unregistered foreign facilities, causing automatic detention at U.S. ports. Learn how to get off IA 99-41, correct your registration, and the role of your U.S. Agent.
Run registration operations with fewer misses
Use these workflows to standardize filing and renewal cycles.