Regulatory Affairs

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).

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