We save your time
Companies often collect a large package of documents, many of which they will not need at the initial stage of registration. During the time spent on clinical trials, part of the registration dossier loses its relevance. Then the procedure is delayed, and the company is forced to update outdated data
NOMINIS
"Our experience and competence allow us to provide full support and assistance in developing the optimal drug registration strategy to bring your product to the pharmaceutical market"
STAGES OF MEDICINE REGISTRATION
1
Conclusion of an agreement
2
Obtaining Documentation
3
Analysis strategy development
4
Dossier preparation
5
Carrying out related procedures for sample transfer
6
Submission to the regulatory authority
7
Support of the regulatory process
8
Obtaining approved documentation
WE PROVIDE THE FOLLOWING SERVICES IN THE FIELD OF DRUG REGISTRATION
- Preparation of the EAEU registration dossier (mutual recognition procedure, decentralized procedure)
- Bringing the national dossier in line with the EAEU standards
- Renewal of state registration, in accordance with national legislation and the EAEU
- GAP analysis of the dossier, development of a registration strategy
- Preparing a dossier for electronic submission in the EAEU format (XML R.022)
- Conducting user testing of the package insert
- Accompanying the registration procedure at any stage
- Writing regulatory documentation and testing methods
- Registration dossier translation services
- Approval and approval of advertising materials
OUR CONTACTS
Address: Tashkent, Mirzo-Ulugbek district. M. Yusuf street, 1A
Phone: +998 97 705 50 30
Mail: info@nominis.uz
Phone: +998 97 705 50 30
Mail: info@nominis.uz
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