Registration

We provide a full package of registration services.

1. Evaluation of documentation (dossier) for a pharmaceutical product, selection of materials for translation required for registration (re-registration). Our specialists analyse the documentation and prepare recommendations on sections of concern.
2. Professional translation of materials.
3. Notarization of translation.
4. Development of methods of quality control for medicines, prescribing information and package leaflets in accordance with the Ukrainian legislation requirements.
5. Quick preparation of a Ukrainian packaging design for dossier submission.
6. Preparation of packaging artworks according to the western manufacturers’ requirements.
7. Registration and cooperation with the authorities of the Ministry of Health of Ukraine (State Pharmaceutical Centre, experts, Public Administration of Medicines, laboratories/reproducibility of procedures for quality control, expert consultations).