Registration Requirements
1. Legal documents:
- Good Manufacturing Practice Certificate (GMP)
- Certificate of Free Sale (CFS)
- Certificate of Pharmaceutical Product (CPP)
- ISO and CE certificates
- Declaration of Conformity document (DOC)
- Power of Attorney (POA)
2. Technical documents:
- Registration dossier
- Certificate of analysis (COA)
- Risk analysis
- Manufacturing process
- Packaging designs
- Clinical studies or Bioequivalency studies (for pharmaceuticals)
- Climate zone 4 stability studies (for pharmaceuticals)
- Validation of methodology (for pharmaceuticals)
3. Samples and Labels
- Finished product samples
- Packaging layouts
- Raw material sample (for pharmaceuticals)
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.
