Simplify Your US Entry – FDA Compliance Made Easy by EVTL

Expanding your business into the United States can be a game-changer. With one of the world’s largest consumer markets and high demand for international products, the US offers Indian exporters vast opportunities. But before your food, cosmetics, dietary supplements, or medical devices can hit American shelves, there’s one crucial step you must complete—US FDA (Food and Drug Administration) compliance. Navigating the complexities of US FDA Registration can be daunting for many businesses. From facility registration to product listing and labeling requirements, there are multiple layers of documentation and processes involved. But you don’t have to do it alone. EVTL India makes FDA compliance simple, fast, and worry-free, ensuring you can enter the US market with full confidence.

What is US FDA Compliance – And Why Is It Important?

The US Food and Drug Administration (FDA) is the governing authority responsible for protecting public health in the United States by ensuring that products such as food, beverages, cosmetics, dietary supplements, pharmaceuticals, and medical devices meet safety, efficacy, and labeling standards.

To export any of these regulated products into the US, your business must complete one or more of the following steps:

Facility Registration

Product Listing

Label Review and Compliance

Appointment of a US Agent (for foreign facilities)

Annual Renewal and Record Maintenance

Failing to comply with FDA requirements can lead to shipment rejections, import alerts, fines, and legal penalties—not to mention damage to your brand reputation.

This is why having the right regulatory partner is critical. That’s where EVTL India comes in.

EVTL India – Making FDA Compliance Effortless

At EVTL India, we understand how overwhelming the FDA process can be—especially for small and mid-sized Indian exporters. That’s why we’ve designed a streamlined compliance service that takes the burden off your team and puts your business on a fast track to the US market.

Here’s how we simplify your FDA compliance journey:

 1. Facility Registration Support

We guide your team through the complete process of registering your manufacturing, processing, or packing facility with the US FDA. This is a mandatory step for any foreign company exporting regulated products to the US.

We ensure that your registration application is accurate, timely, and free from errors that could lead to costly delays.

 2. Product Listing and Classification

Different product categories have unique requirements under the FDA. EVTL India assists in identifying your product’s correct classification and listing it appropriately within the FDA’s database systems (such as FURLS and DRLM).

We also help you avoid critical errors in product descriptions, ingredients, or formulations.

 3. DUNS Number Assistance

The FDA requires a DUNS (Data Universal Numbering System) number for facility registration. We support you in acquiring this unique identifier quickly and efficiently—without technical confusion.

 4. Appointing a US Agent

As a foreign exporter, you are required to appoint a US-based Agent who will serve as a point of contact for the FDA. EVTL India helps you appoint a verified US Agent from our trusted network to meet this requirement professionally and affordably.

 5. Label Review and Compliance

Incorrect labeling is a common reason for product rejections. Our experts thoroughly review your product labels to ensure that ingredient lists, health claims, nutrition facts, and warnings comply with FDA standards.

We also help you adjust labels to meet US market expectations while staying within the legal framework.

 6. Renewal and Post-Registration Support

FDA registration is not a one-time event. EVTL India monitors renewal deadlines and handles biannual updates, notifications, and ongoing documentation so your registration always stays current.

Industries We Serve

EVTL India supports a wide range of businesses and industries with tailored FDA compliance services, including:

Packaged food and snacks manufacturers

Ayurvedic and herbal product exporters

Cosmetics and personal care companies

Medical and surgical device producers

Nutraceutical and supplement brands

Pharmaceutical manufacturers

Whether you’re a startup or an established exporter, our solutions are designed to fit your scale and goals.

Why Choose EVTL India?

Choosing EVTL means choosing a partner who understands your challenges and delivers results:

✔ In-Depth Regulatory Expertise

Our experienced consultants know the ins and outs of FDA regulations and help you avoid common pitfalls.

✔ End-to-End Service

From documentation and registration to renewals and labeling—we cover everything under one roof.

✔ Fast Turnaround Time

We accelerate your US entry by minimizing back-and-forth errors and ensuring smooth approval.

✔ Affordable and Transparent Pricing

No hidden costs. No surprise delays. Just reliable support at competitive rates.

✔ Trusted by Indian Exporters Nationwide

Our clients include hundreds of Indian businesses that have successfully entered the US market with our guidance.

What’s at Risk If You Skip Compliance?

Ignoring or mishandling FDA compliance can result in:

Shipment detention at US ports

Product seizures or recalls

Import alerts and legal notices

Loss of trust with US buyers and distributors

Permanent damage to your brand reputation

In contrast, working with EVTL India ensures smooth market access, peace of mind, and enhanced brand credibility in the United States.

Conclusion

If you're ready to take your products to the global stage, don’t let compliance barriers slow you down. Let EVTL India guide you through the US FDA Registration Consultant and approval process with ease, clarity, and efficiency.