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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp Industry Expert

At Registrar Corp, we are more than a company; we are a team of over 200 dedicated experts from diverse backgrounds including former FDA officials and seasoned industry specialists. Our mission has been to simplify the path to compliance for businesses around the globe.

Background

Established in 2003, Registrar Corp has developed a reputation as the leader in global compliance, catering to industries including food and beverage, cosmetics, drugs, and medical devices. Our team leverages comprehensive tech-enabled services and deep regulatory knowledge to provide streamlined solutions that address the challenges of compliance across various sectors.

Latest from Author


56 Results
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.

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.

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.

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.

Understanding the Five DMF Types: A Guide to FDA Drug Master Files

Understand all 5 FDA DMF types—how to use them, what to avoid, and how to turn confidential submissions into strategic regulatory assets.


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