Your FDA Compliance Partner

Trusted by Global Brands

A Simple Lane to America

We provide US Agent, FDA registration, and full compliance support for OTC drug, and cosmetic product companies worldwide. We will take care of the regulatory works, so you could focus on the market.

 Contact us

Miami, Florida, USA

US-based company

Regulatory Expertise

Regulatory Affairs experts experienced for FDA Communication

Transparent Pricing

Price published on website

Services

US Agent

Designated agent who resides in the United States to support FDA communications for foreign company

OTC Drugs

Drug establishment registration, Product listing, Label review and Renewal

Cosmetics

MoCRA facility registration, Product listing, Label review and Renewal.



Why Brands Choose Asla Partners

FDA-Focused Expertise

Our team brings hands-on pharmaceutical regulatory experience and a practical understanding of FDA requirements. We help you identify potential issues early and move forward with greater clarity.

US-Based Support

With a U.S.-based entity, we provide a reliable U.S. point of contact for international companies navigating FDA requirements. We help keep regulatory communications and submission steps clear, organized, and timely.

Transparent Pricing

We publish pricing for all services on our website, so you can review costs and choose the support that fits your business needs. We clearly outline the service scope, process, and timeline before work begins.

Real Human Support

Every inquiry is carefully reviewed by a real regulatory professional
who understands the FDA requirements for your product. You will receive clear, relevant guidance—not automated or generic responses.

Support Beyond Registration

FDA compliance support extends beyond the initial submission. We provide annual reminders for recurring registration and listing obligations, helping your business stay informed and maintain continuity.

Trusted Globally

We understand the practical challenges international brands face when entering the U.S. market. Our support is designed to bridge regulatory, language, and operational gaps across borders,
making FDA compliance processes more clearer.

FAQ

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?

Please share your company name, country, product type, and a brief description of the support you need.

If available, include any existing FDA registration or listing details. This helps us identify the relevant services and information needed to proceed.

If you’re unsure where to start, simply describe your product and your plans for the U.S. market.
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.