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US FDA Registration Consultation
Expanding your business into the United States? Then, securing US FDA Registration is not just a regulatory requirement—it’s a critical step to ensure product acceptance, brand trust, and long-term success in one of the world’s most competitive markets.
EVTL India, a leading global compliance consultancy, offers end-to-end US FDA registration consultation services to help manufacturers and exporters navigate the complex regulatory landscape with confidence and ease.
What is US FDA Registration? - Overview
The U.S. Food and Drug Administration (FDA) mandates registration for every company that manufactures, processes, packs, or stores food, drugs, cosmetics, or medical devices intended for the U.S. market. This registration ensures your products meet FDA’s stringent quality, safety, and labeling standards.
Without this registration, your goods can be:
- Detained at U.S. ports
- Returned to the country of origin
- Rejected by importers or distributors
- Subjected to legal action or fines
Why Choose EVTL India for US FDA Registration?
With vast experience in global regulatory compliance, EVTL India is your trusted partner for smooth and secure FDA compliance. Our local presence in countries including India, USA, UK, Germany, Australia, South Korea, Thailand, Taiwan, Malaysia, and Vietnam ensures on-ground support wherever you are.
By appointing EVTL India as your US FDA Agent, you benefit from:
- A centralized point of contact, reducing dependency on multiple importers/distributors
- End-to-end support from facility registration to label compliance
- Continued compliance guidance, even as your partnerships change
Our Step-by-Step US FDA Registration Process
Step 1- Appoint a US FDA Agent & Register Your Facility: We help you appoint a reliable US Agent and initiate establishment registration, including DUNS number assistance.
Step 2- Identify Product Classification: Our experts analyze whether your product falls under FDA regulation and determine its applicable product code and regulatory pathway.
Step 3- Label & Packaging Review: Labeling is a critical component of FDA compliance. We ensure your packaging aligns with FDA standards for cosmetics, drugs, devices, or food items.
Step 4- Ensure Good Manufacturing Practices (GMP): We help you align your manufacturing process with FDA GMP guidelines—essential for product safety and successful audits.
Step 5- Submit & Secure FDA Registration Number: After complete documentation and facility details submission, we follow up with the FDA to obtain your official registration number.
What Makes FDA Registration with EVTL India Different?
- Global Support: Offices across multiple continents ensure localized communication and faster response.
- Expert Guidance: Regulatory professionals with years of hands-on experience in FDA submissions.
- Transparency: Clear communication, realistic timelines, and compliance-first strategies.
- Cost-Efficient Packages: Flexible pricing for startups, MSMEs, and large exporters alike.
Key Benefits of FDA Registration
Work with EVTL India – Your One-Stop FDA Compliance Partner
Whether you are a manufacturer of dietary supplements, medical devices, packaged foods, or cosmetics, EVTL India is here to guide you from start to finish. We simplify the regulatory process so you can focus on your core business—growth and innovation.
Let EVTL India be your reliable partner for seamless US FDA registration and consultation.
Contact us today to schedule your first consultation and start your journey toward compliant and profitable exports to the USA!
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Our Services
For our EPR Registration, EVTL India provided outstanding support. They helped us understand the requirements and ensured timely compliance. Their efficiency made the process hassle-free, and we’re now fully compliant with the regulations."*
Atul Singh
Product SpecialistEVTL India made ISI certification easy and stress-free. Their expert guidance and thorough handling of the documentation helped us get certified on time. The process was smooth, and we are very satisfied with their service.
Vishal Vikram Singh
Sr Manager – RegulatoryEVTL India’s team provides exceptional support as a BIS Certification consultant. Their professionalism and in-depth knowledge of regulatory standards saves time and ensured a fast and efficient certification process.
Terutaka Ogawa
Country HeadThanks to EVTL India, we quickly obtained an ISI Mark Certificate. Their team’s expertise and attention to detail ensured that we met all requirements smoothly. Highly recommend their services!
Pankaj Gupta
Q&R Lead- IndiaEVTL India stands out as a top BIS consultant in India. Their expertise and proactive approach make navigating regulatory compliance seamless, ensuring every project meets the highest standards. I highly recommend them for compliance needs in India.Shrek Li, Regulatory Compliance Expert, China
Shrek Li
Account DirectorGot my ISI mark certification done at EVTL India along with CRS for my IT product. EVTL also provided my company rn enterprises with inhouse lab setup at my manufacturing unit.
RN Enterprises
We had an excellent experience with EVTL for ISI certification. The entire process was smooth and hassle-free. Their team was supportive and very professional and kept us updated throughout. Highly recommend their services!!
Mehandru Casting pvt ltd
I would like to express my gratitude to Divyanshu Sir for his invaluable support with the BIS ISI registration of electric Toy. We truly appreciate your assistance and will certainly recommend your services.
Shksham Yadav
I took their service for baby category for both electric and non electric they did a smooth job getting me the BIS certificate with out any problem.
hemanth sai Bussetti
They have provided us with great service, getting our ISI certification done hassle free. For our POV Domestic Ro systems. Thanks EVTL India Family. great work
Mr. Chudmunge
We have try more vendor for ISI mark certificate but EVTL india is best support team and earlier time get the license. Thanks Evtl India family
