Consulting
Consulting of radiopharmaceutical manufacturers for compliance with regulation and additional services
Areas
of our consulting
of our consulting
Our team is ready to consult you on any issues related to radiopharmaceutical production
01. Development of pharmaceutical quality system documentation for radiopharmaceutical production
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Development of validation master plan, policy on quality and necessary SOPs
• equipment
• clean rooms
• air conditioning systems
• water treatment systems
• systems for preparation and distribution of process gases
• suppliers
• clean rooms
• air conditioning systems
• water treatment systems
• systems for preparation and distribution of process gases
• suppliers
• purification processes
• analytical procedures
• analytical procedures
• technological process
04. Technologies / methods implementation for production of promising (new for the Russian market) radiopharmaceuticals
05. Audit of radiopharmaceutical production for compliance with RF / EAEU / EU GMP requirements
06. Preparation for obtaining licenses and certificates on RF / EAEU / EU GMP requirements
• development / adjustment of documentation in accordance with regulations
• development of necessary SOPs for the pharmacovigilance system
• provision of the Authorized Person for Pharmacovigilance
• development of necessary SOPs for the pharmacovigilance system
• provision of the Authorized Person for Pharmacovigilance
• preparation of periodic safety update reports
• conducting audits of the pharmacovigilance system
• conducting audits of the pharmacovigilance system
08. Registration of medicines in the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) and EU countries
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• registration dossier preparation
• support during registration process
09. Registration of devices as measuring instruments
10. Support during obtaining medical license
11. A comprehensive approach to organizing the production of radiopharmaceuticals at the customer's site
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• providing a qualified team to organize the production of radiopharmaceuticals
• service support (including installation and commissioning, equipment qualification)
• support in obtaining licenses from regulatory authorities
• provision of consumables and spare parts in time
• service support (including installation and commissioning, equipment qualification)
• support in obtaining licenses from regulatory authorities
• provision of consumables and spare parts in time
• technologies / methods implementation for production of promising (new for the Russian market) radiopharmaceuticals
• attracting patients due to the use of new / unique for the Russian market radiopharmaceuticals and a wider range of solutions for diagnostic and therapeutic problems
13. Design qualification of radiopharmaceutical production in compliance with RF / EAEU / EU GMP requirements
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