AGROVETCONSULTING
Registration of medicinal products for veterinary use and feed additives for animals, support of inspection processes for compliance with GMP requirements and licensing for the right to carry out pharmaceutical activities
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, SC "Institute of Pharmaceutical Technologies" 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.
GMP INSPECTION
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.
REGISTRATION
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.
EAEU
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.
PHARMACOVIGILANCE
POST-REGISTRATION ACTIVITY
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.
RESEARCH
ORGANIZATION OF RESEARCH
Selection of a laboratory for additional research: bioequivalence, preclinical studies, efficiency studies, etc.;
LICENSING
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.
CONSULTING SERVICES
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.
REGISTRATION
PESTICIDES AND AGROCHEMICALS
Organization of registration tests and examination of regulations for the use of pesticides, agrochemicals and fertilizers. Comprehensive support of the registration process to ensure compliance with laws and regulatory requirements.
Terms and costs of supporting the registration process of veterinary medical products and consulting services
1.Support of the inspection process of the production site of the manufacturer of medical products for veterinary use for compliance with GMP requirements
Terms and cost... by request*
*The final cost of the service depends on the number of production sites, the number of medical products submitted for inspection.
2. Registration of a medicinal product for veterinary use on a turnkey basis
Terms and cost... by request*
*The final cost of the service depends on the condition and availability of the initial documents necessary for the formation of the registration dossier, the number of target animal species for which the medicinal product is used, the number of active pharmaceutical substances that make up the medicinal product.
3. Bringing the dossier in line with the Rules of the EAEU, in accordance with the Decision of the Council of the Eurasian Economic Commission dated January 21, 2022 N 1:
*The final cost of the service depends on the conditions and availability of the initial documents required for the formation of the registration dossier.
4. Registration of a feed additive for veterinary use on a turnkey basis:
*The final cost of the service depends on the conditions and availability of the initial documents necessary for the formation of the registration dossier, the number of target animal species for which the feed additive is used, the number of active ingredients that make up the feed additive.
5. Post-registration activities
*The final cost of the service depends on the type of change that needs to be made to the registration dossier.
6. Pharmacovigilance:
7. Assistance in selecting a laboratory (research centers) for additional research
Terms and cost... by request
8. Support in the process of obtaining a license for pharmaceutical activities for medicinal products for veterinary use
Cost... from 150 000 rubles
9. Registration of pesticides, agrochemicals
9.2 Organization of examination of regulations for the use of a pesticide or agrochemicals;
9.3 Analysis of test results, preparation of all necessary documents (a profile) and support of the registration procedure.
Terms... from 14 months from the beginning of seasonal field state tests.
Cost... from 2.7 million Russian Rubles.
10. Translation of documentation into Russian
Terms... by request
An important point of our standard agreement is the section on confidentiality of information, the provisions of which we strictly observe in our work.
To find out how to register your products quick, please contact us at +7 (495) 256-08-81 or email reg@avc.vet.
If you have not found the solution you need among our services, we will be happy to discuss with you the issue of possible cooperation.
More than 20 medicinal products for veterinary use registered
Pharmacovigilance is carried out for 30 medical products for veterinary use
More than 10 animal feed additives registered
Conducted more than 10 inspection procedures
More than 25 sites have been licensed
Some possible scenarios
Scenario 1: Your company already has a registration department.
Scenario 2: You already using the services of an external agency or agent.
Scenario 3: You or your colleagues register products "in the load", postpone the implementation of other priority tasks, curse the work with "papers" and correspondence with foreign representatives.
Scenario 4: Your medical products for veterinary use are registered in the Russian Federation, but there is no organization responsible for pharmacovigilance, for accepting claims from the consumer and submitting periodic safety reports.
Scenario 5: A foreign pharmaceutical manufacturing company plans to start a business in Russia, but does not know where to start, including what steps are necessary to obtain a Russian GMP certificate.
