J&B Consulting
FDA OTC Drug Registration Consulting
Expand your brand into the U.S. pharmaceutical market with confidence. Our FDA OTC Drug Registration Consulting Service is designed to help manufacturers, distributors, and private labelers ensure compliance with FDA regulations for Over-the-Counter (OTC) drug products.
NDC (National Drug Code) registration & SPL submissions
Facility registration and annual renewal (eDRLS & CDER Direct)
U.S. agent service for foreign facilities
Label compliance review (per 21 CFR 201)
Monograph ingredient evaluation & classification
Audit preparation and FDA inspection readiness
Who Needs This Service?
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Cosmetic brands launching OTC drug products (e.g. acne, sunscreen, dandruff)
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International manufacturers seeking U.S. market entry
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Contract manufacturers (CMOs) and private labelers
Why Choose Us?
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Proven expertise in FDA OTC drug compliance
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End-to-end support, from registration to label approval
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Fast turnaround and cost-effective solutions