Current Russian regulations require quite comprehensive preclinical study program for every pharmaceutical submitted for state registration. Preclinical study report in any case should contain following points:
One should keep in mind that for generic products or biosimilar those studies should be comparative vs original product.
It is not obligatory to conduct that set of preclinical studies in Russia, nevertheless most applicants conduct such studies locally with help of experienced CRO in Russian centers. The reason is simple – like for clinical studies there are MoH-approved guidelines for conduction of preclinical study for majority of clinical pharmacology product classes, specific requirements in normative regulatory base as well as locally established GLP standard in Russia.
Our specialists has extensive experience in managing preclinical studies in Russia with contacts in all GLP-compliant study centers in Russia. We would be glad to help you with fast and free calculation of preclinical study budget and timeline. Also our consultation concering conduction of preclinical studies for registration and available options to choose will be granted to you. Our experts will discuss every details of your project and in any case you will receive working solution that will bring you clear picture to proceed with your project safely.