General Industry

Stay informed about the latest trends within the regulatory landscape in the global drug industry with our expert insights.

Master Files

Biologics

Registration & Listings

General Industry

Stay informed about the latest trends within the regulatory landscape in the global drug industry with our expert insights.

Master Files

Biologics

Registration & Listings

General Industry

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Featured General Industry Articles

Does FDA Consider My Product A Cosmetic Or Drug?

Discover how FDA evaluates products as a a cosmetic, drug, or both and how you can easily assure compliance with regulations.

Latest General Industry Compliance Articles

A Compliance Blueprint to Generic Drug Market Access

Understand GDUFA user fees, inspection rules, and compliance tips for generic drug makers and CMOs. Avoid delays and secure faster US market access.

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.

FDA Red 3 Ban: Compliance Deadline & Reformulation Tips

Learn how the FDA’s Red 3 ban impacts food and drug makers. Discover compliance deadlines, reformulation challenges, and key industry insights.

Ensuring Compliance with U.S. FDA Adverse Event Reporting (AER) Regulations for Drug & Dietary Supplement Exporters

Ensure FDA compliance with Adverse Event Reporting (AER) for pharmaceuticals & dietary supplements. Avoid penalties & protect your U.S. market access.

Ingredient & Formulation Compliance for Seamless US Market Entry From India

Ensure ingredient and formulation compliance for pharmaceutical, medical device, & food exports from India.

Unlocking the Benefits of Online Purchasing in Local Currency

As purchasing online becomes more common for businesses, the benefits of buying in your local currency are undeniable.