Our specialists have extensive experience in planning and preparing documents for clinical trials of medicinal products. During the entire period of work, more than 150 document packages have been developed and not a single rejection has been received from the regulatory authorities.
Services
01
Development and registration of medicinal products
Creation and/or refinement of preclinical and clinical research programs for any group of drugs, of any complexity
Preparation and finalization of instructions for use of MP (SmPC, product insert)*
Preparation of registration dossier modules in CTD format** according to EAEU regulations
Preparation of scientific reviews of preclinical and clinical studies
Development of initial documentation packages for the conduct of clinical trials of all phases (protocol, investigator’s brochure, subject information sheet, etc.)
Review of results/reports of preclinical and/or clinical studies at various stages, assessment of claims
* MP - Medicinal Product, SmPC - Summary of Product Characteristics
** GTD - General Technical Document
02
ost-registration services
Preparation of scientific reviews/articles for publication in scientific journals listed in Web of Science, SCOPUS, RSCI
Development of research and development (R&D) programs for post-registration use of medicines
03
Development of documents within the pharmacovigilance system
Preparation of reports on the safety of medicinal products under development (RSUR)
Preparation of periodic safety update reports (PSUR)