Certifications
Nubenco USA holds the following certifications that will be made available upon request to all qualified distributors.
Click the following links to view Nubenco certifications.
- CE Class IIa
- CE Class IIbc
- ISO 9001
- ISO 13485
- United States FDA Product Listing (registration #: 2434060) *
- US UDI Codes *
- US FDA Establishment Registration
- CFG (Certificate to Foreign Government) *
- New Jersey, USA GMP
- Nubenco Wholesale Drug License
- US Free Sale Certificate
*CFR 820 compliance pending. Documents available upon completion
Registration Process
Registration submission
After all documents have been prepared and samples produced, complete registration files are submitted for approval.
It is vital to the success of not only the products being registered, but also all future products to be registered by Nubenco, that accuracy is absolute. We meticulously verify the accuracy of all documents and samples we submit.
Legal documents
Evidence that manufacturers and products are registered by a Stringent Regulatory Authority (SRA).
Sample preparation
Samples are required by most registering countries for testing in order to complete product registration.
Samples are produced according to the international standards required for product registration.
Packaging design
Packaging is designed according to the regulation requirements of each importing country. Superior modern packaging is one of the most important aspects in marketing our products.
Nubenco products are packaged with the best materials with the environment and product integrity in mind.
Agreements
All business relationships start with valid agreements in place, for distribution and manufacturing purposes.
Terms, conditions and specifications of Nubenco-client relationship are defined by both parties and remain confidential.
Dossier preparation
Nubenco begins preparing all necessary documents according to the importing country’s requirements.
Complete technical dossiers and other documents needed for registration are vital to register products in any country. Ministries of Health around the world know that when Nubenco registers its products, the process will be efficient and precise.
