Miami, Florida, USA
US-based team
Expertise
Former RAs from international pharma with experience of working frequently with FDA
Transparent Pricing
Price published on website
Slideshow
A
Simple
Lane to
America
Why Brands Choose Asla Partners
FAQ
What is an FDA U.S. Agent?
A foreign facility that is intended to register with FDA must designate a U.S. Agent as part of its registration. This includes foreign drug establishments and foreign cosmetic facilities required to register under MoCRA.
The U.S. Agent must reside in the United States or physically present in the United States. The agent reviews, routes, and responds to FDA communications, including emergency communications, and inspection coordination when applicable.
A U.S. Agent designation does not mean that FDA has approved the facility or product, or that the product may legally be marketed in the United States.
Does FDA registration mean my product is FDA approved?
No. FDA establishment registration, cosmetic facility registration, and product listing are not product approvals and do not by themselves authorize U.S. marketing.
An OTC drug may be legally marketed only if it complies with an applicable FDA OTC drug monograph or, is marketed under an FDA-approved NDA or ANDA. Cosmetics generally do not require FDA premarket approval, except for color additives. However, they must comply with applicable U.S. safety, labeling, and other regulatory requirements.
What do I need to do to market an OTC drug in the United States?
To bring an OTC drug product to the U.S. market, you may need FDA establishment registration, an FEI number, drug product listing in SPL format, and an NDC Labeler Code. Foreign drug manufacturing facilities must also designate a U.S. Agent as part of FDA registration.
You may also need an OTC drug label compliance review to confirm that Drug Facts content, active ingredients, directions, warnings, and product claims meet applicable FDA requirements. After registration and listing, annual establishment renewal and drug-listing certification or updates are needed to keep FDA records current.
What do I need to do to market a cosmetic product in the United States?
To bring a cosmetic product to the U.S. market, you may need MoCRA facility registration, an FEI number, and a cosmetic product listing to the FDA. Foreign cosmetic facilities must also designate a U.S. Agent as part of the FDA registration.
You may also need a cosmetic label compliance review to confirm that the ingredient declaration, required label elements, and product claims meet applicable U.S. requirements. After registration and listing, cosmetic product listings need to be updated annually, and facility registrations need to be renewed every two years.
What information should I prepare to request support?
To help us understand your needs, please share your company name and country, the type of product you plan to introduce in the United States, and a brief description of your request.
It is also helpful to let us know whether your product is an OTC drug or cosmetic, whether it is manufactured outside the United States, and whether you need support with a U.S. Agent, FDA registration, product listing, renewal, or label review. To help us identify which services may be relevant to your business, please also share any available product label, ingredient information, manufacturing-facility details, or existing FDA registration information.