Supplier profile
Contact details
Cratia Ltd. (Ukraine) provides complete range of regulatory assistance services of medicinal products, pharmaceutical substances, medical devices, immunobiological products, cosmetic and nutritions:
- preliminary consulting service (local requirements to registration dossier, structure of Module 1 of CTD format, amount of State fees etc.);
- translation of documentation (dossier) to Ukrainian language;
- localization of specific documents (such as instruction for use, control methods of finished product);
- receipt of specific decisions, approvals and scientific advices;
- submission of the Application and dossier to State Authorities (state Pharmacological Center of Ministry of Health of Ukraine, State Agency of medicinal products and medical devices, State Sanitary Agency, expert com ...missions and other government bodies);
- representing interests of Applicant during expertise of registration materials;
- receipt of import approval and custom clearance of not registered samples for registration purposes;
- specific services: pharmacovigilance, recognition of GMP certificate; Read more
- preliminary consulting service (local requirements to registration dossier, structure of Module 1 of CTD format, amount of State fees etc.);
- translation of documentation (dossier) to Ukrainian language;
- localization of specific documents (such as instruction for use, control methods of finished product);
- receipt of specific decisions, approvals and scientific advices;
- submission of the Application and dossier to State Authorities (state Pharmacological Center of Ministry of Health of Ukraine, State Agency of medicinal products and medical devices, State Sanitary Agency, expert com ...missions and other government bodies);
- representing interests of Applicant during expertise of registration materials;
- receipt of import approval and custom clearance of not registered samples for registration purposes;
- specific services: pharmacovigilance, recognition of GMP certificate; Read more