We can offer these services for you:
– Review of the dossier, consultation service;
– Preparation of all administrative documents;
– Consultation of quality, non-clinical and clinical experts;
– Dossier preparation and submission (changing format if need) in eCTD;
– Process coordination and communication during National, MRP/DCP procedures;
– Consolidate dossiers;
– Registration, renewal, all types of variations;
– Layout preparation, checking, approval;
– Translation of medicinal texts;
– Notification of food supplements and medical devices;
– Consultation of Reimbursement of medicines (LT, LV, EE).
Contact email: regulatory@itlconsult.com
