USFDA Establishment Registration

Navigating Regulatory Requirements for Market Access

Establishment registration with the U.S. Food and Drug Administration (FDA) is a critical step for companies looking to manufacture, pack, label, or import medical devices into the United States. This process ensures compliance with FDA regulations and enables your products to enter the U.S. market legally. IQzyme offers expert guidance and support to streamline the establishment registration process, helping you meet regulatory requirements and achieve market success.

Our USFDA Establishment Registration Services

Eligibility Assessment and Planning

Regulatory Review: Assess your business’s eligibility for FDA establishment registration, ensuring that all necessary criteria are met.

Strategic Planning: Develop a tailored registration strategy that aligns with your business objectives and regulatory requirements.

Registration Process Support

FDA Account Setup: Assist in setting up an account in the FDA’s FURLS (FDA Unified Registration and Listing System) database, ensuring all necessary information is accurately entered.

Facility Registration: Guide you through the process of registering your establishment, including the submission of required documentation and payment of registration fees.

Product Listing and Compliance

Product Identification: Help identify and classify your medical devices according to FDA standards, ensuring accurate product listing.

Compliance Assurance: Ensure your products comply with relevant FDA regulations, including labelling and quality system requirements.

Regulatory Updates and Renewals

Ongoing Compliance: Provide ongoing support to maintain compliance with FDA regulations, including monitoring for regulatory updates and changes.

Annual Renewals: Assist with the annual renewal of your establishment registration, ensuring continued compliance and market access.

Training and Advisory Services

Regulatory Training: Offer training programs to enhance your team’s understanding of FDA regulations and requirements.

Advisory Support: Provide expert advice on navigating FDA regulatory challenges and achieving successful market entry.

Why Choose IQzyme for USFDA Establishment Registration?

Regulatory Expertise: Our team has extensive experience in navigating the FDA establishment registration process, ensuring compliance with U.S. regulations.

Tailored Solutions: We offer customised registration services that align with your specific business and product needs.

Comprehensive Support: From initial registration to ongoing compliance, we provide end-to-end support to facilitate your market entry.

Commitment to Compliance: We are dedicated to helping you achieve regulatory compliance and access the lucrative U.S. market.

Streamline Your FDA Registration with IQzyme

Ensure your establishment is registered with the FDA and ready to access the U.S. market with IQzyme’s expert support. Contact us today to learn how we can assist you in meeting regulatory requirements and achieving market success.