Beyond Registration. Complete FDA Support.
OTC products, Prior Notice, import regulatory support and detained shipments. When your need goes beyond registration, we assess it first and support it with the same team.
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Our other FDA services
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OTC Product Support
Classification, drug establishment registration, listing and Drug Facts labels.
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Prior Notice Support
Prior Notice for food shipments with complete and consistent documents.
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Import Regulatory Support
What your U.S. importer needs from you before the goods move.
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Shipment Detained Support
Urgent review of the notice and documents when FDA holds a shipment.
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Other FDA-Regulated Products
Tell us about the product; we confirm whether it is within our scope before quoting.
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Regulatory Consulting
A 60-minute Regulatory Consultation for strategy, documents or a specific case.
OTC products
Antiseptics, hand sanitizers, sunscreens and other over-the-counter drugs are regulated as drugs in the U.S. We start by confirming the classification and the applicable OTC monograph, then build the path.
Request an OTC Assessment- Classification
- Cosmetic, OTC drug or both, based on claims, ingredients and intended use.
- Drug establishment registration and listing
- Registration of the establishment and listing of each product (21 CFR 207).
- Drug Facts label
- Format and content under 21 CFR 201.66.
- Monograph conditions
- Active ingredients, concentrations and claims allowed for the category.
- Manufacturing
- Drug cGMP readiness under 21 CFR 210 and 211.
- Laboratory testing
- We manage the testing that OTC claims require, quoted within the scope.
Prior Notice support
Every shipment of food imported into the U.S. needs Prior Notice before it arrives. We prepare it with the information you provide.
What we ask for
- Product and quantities
- Shipment and transport details
- Manufacturer and shipper
- Importer and consignee
- Applicable documents
Our process
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Consultation
We understand the product and the situation.
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Strategy
We define what applies and in what order.
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Implementation
We prepare documents and submissions with you.
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Resolution
We follow up on the open requirement.
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Ongoing Support
We stay available within your scope.
Regulatory Support for Global Growth
Ground transport, importers, brokers and FDA requirements meet at the border. We prepare the regulatory side so your shipment is not the one waiting for a missing document.
Have a case that does not fit a category?
Call or WhatsApp us. We will tell you whether it is within our scope before you send documents.
Need FDA support beyond registration?
Tell us about the product and the requirement.