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1. Granting of marketing authorization (all type of procedures (DCP, MRP and NP)
• Preparing of application (full, generic/hybrid);
• Marketing authorization of medical products;
• Evaluation of application.
2. Renewal of marketing authorization for all procedures (medicines, homeopathic, traditional herbal products)
• Variations submissions (Type IA, IB, II);
• Non variation changes;
• PSUR submissions;
• Changes of classification;
• Marketing authorization transfers.
3. Design of packages, leaflets, additional stickers and approval of this material
4. Please note that we can offer you eCTD and Nees service
• We can prepare new eCTD dossier;
• We can prepare new Nees dossier;
• We can prepare continued eCTD and Nees sequences;
• We can modify Nees format to eCTD;
• We can publish your dossiers;
• And etc.
If you need further information please don‘t hesitate to contact:
Regulatory Affairs Manager
+370 601 24040
Regulatory Affairs Officer
+370 615 61636