AGROVETCONSULTING (AVC) will help you to meet the requirements of veterinary legislation in the field of circulation of medical products for veterinary use. We have been working in the field of registration of medicines and feed additives since 2004. Our partners include GLOBALVET GROUP, KELA N.V., MSD ANIMAL HEALTH, BAYER, ELANCO, NORBROOK LABORATORIES LIMITED, CHR. HANSEN, EASTMAN, DIAFARM, VETOQUINOL and many others.
Does your company sell and register veterinary medicines or feed additives on the territory of the Russian Federation?! Then you know that registration is a complicated process. The successful completion of the process requires knowledge and experience of interaction with regulatory authorities.
GOOD MANUFACTURING PRACTICE RULES
Support in process of inspection of the manufacturer site of medicines for veterinary use for compliance with the requirements of good manufacturing practice. Preparation of a set of documents for submitting an application to the Rosselkhoznadzor, consulting services.
MEDICAL PRODUCTS AND FEED ADDITIVES FOR VETERINARY USE
Registration of a medicinal product or feed additive for veterinary use on a turnkey basis; Acceleration of the preparation time of a dossier for a medicinal product and a feed additive.
BRINGING THE DOSSIER IN ACCORDANCE WITH THE RULES
Bringing the dossier in accordance with the Rules of the EAEU. Due to entry into force of the Decision of the Council of the Eurasian Economic Commission dated January 21, 2022 N 1 "On the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union" from March 13, 2024, it is required to provide a dossier of already registered medicinal products for veterinary application, in accordance with these Rules.
Preparation and submission of periodic reports on the safety of medicinal products for veterinary use registered in the Russian Federation in IS Galen + making changes to the dossier of registered medicinal products and feed additives.
ORGANIZATION OF RESEARCH
Selection of a laboratory for additional research: bioequivalence, preclinical studies, efficiency studies, etc.;
OBTAINING A LICENSE FOR PHARMACEUTICAL ACTIVITIES
Consultations on all issues related to the procedure for obtaining a pharmaceutical license, preparation of a complete set of necessary documents, verification of compliance of the premises with licensing requirements and, as a result of preparation, submission of documents for licensing to the Rosselkhoznadzor.
TRANSLATION OF DOCUMENTATION
REGISTRATION DOSSIER OF MEDICAL PRODUCTS, FEED ADDITIVES AND PRODUCTION SITES
Translation of registration dossier documents, including documents on the quality of medical products and active pharmaceutical substances, validation documents (pharmacopoeia articles, methods, stability studies, certificates of analysis, justification of specifications, safety data sheets, characteristics of impurities), documents on manufacuring and production sites, GMP inspection reports, reports on clinical and preclinical studies, documentation and pharmacovigilance reports and many other documents.
Consultations both on simple issues and on issues requiring the study of the situation, obtaining additional documents or additional requests to the authorized bodies. The area is veterinary legislation.