Latest Registration & Listings Compliance Articles
How Pharmaceutical Companies Can Simplify Active Substance Master File Procedures

Managing EMA ASMF submissions can be complex. Learn how pharmaceutical companies simplify Active Substance Master File procedures & regulatory management.

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Why FDA Is Detaining More API & Bulk Ingredient Shipments — and How to Avoid It

Avoid FDA API and bulk ingredient shipment detentions. Learn common registration, listing, and NDC errors—and how Registrar Corp helps keep imports compliant and moving.

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FDA Scrutiny in 2026: Top 5 Regulatory Risks for Drug Manufacturers

FDA scrutiny is intensifying. Learn the 5 critical regulatory risks facing drug manufacturers in 2026 and the strategic shift you must make to protect market access.

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FDA New Drug Applications (NDA): A Complete Guide to 505B1 Approval

Learn how to navigate the FDA’s 505B1 NDA process—from data requirements to approval timelines, labeling, and compliance. Avoid delays with expert guidance.

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505B2 NDA Explained: A Strategic Pathway to FDA Drug Approval Using Existing Data

Learn how to leverage the 505B2 NDA pathway for faster FDA approval. Use existing data, reduce costs, and gain exclusivity for differentiated drug products.

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Navigating eCTD Submissions: A Complete Guide for FDA Compliance and Global Strategy

Learn how to prepare eCTD submissions for FDA and global markets. Get up to speed on version 4.0, lifecycle tips, and best practices for compliance success.

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