Latest General Industry Compliance Articles
European Regulatory Agencies and Market Access: Understanding HMA, EDQM, Swissmedic, and MHRA 

Understanding the various European Pharmaceutical Regulatory Authorities and how they affect market access, including HMA, EDQM, Swissmedic, and MHRA.

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FDA Expands Sunscreen Options for the First Time in 20 Years: What Bemotrizinol Addition Means for Manufacturers 

FDA expands sunscreen option for first time in 20 years. Bemotrizinol, widely used outside of U.S. has been added to the OTC sunscreen monograph.

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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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What is OMUFA? A Complete Guide to FDA Fees and Compliance for OTC Drug Manufacturers

A complete guide to OMUFA: Learn how OTC drug makers can manage FDA facility fees, OMORs, exemptions, and stay compliant under the CARES Act framework.

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FDA Drug Amount Reporting: The Deadline You Can’t Ignore

Don’t risk public exposure on the FDA’s noncompliance list. FDA Drug Amount Reporting is now enforced under Section 510(j)(3) of the FD&C Act.

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How to Get FDA Approval

Do food, medical devices, drugs, and cosmetics need FDA approval? Read our guide on how to get FDA approval for your regulated product.

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