About us
Provision of pharmacovigilance services, organization of clinical studies of medicinal products and preparation of scientific documentation for registration in EAEU
Services
We provide services in 3 areas
Pharmacovigilance
Outsourcing of pharmacovigilance (PVA), providing a qualified person for pharmacovigilance (QPPV), a Contact person for pharmacovigilance in EAEU countries. Literature monitoring. Writing periodic safety update reports and risk-management plans.
Pharmacovigilance in clinical trials. Medical monitoring.
Documents of registration dossier
Compilation of SmPC and PIL, user testing of the PIL.
Writing modules 2 (2.3-2.7) CTD: quality reviews, of non-clinical pharmacology and clinical reviews.
Writing modules 2 (2.3-2.7) CTD: quality reviews, of non-clinical pharmacology and clinical reviews.
Our team has practical experience in preparing documentation for the EAEU, FDA, EMA
Research of medicinal products
Organization of phase I-IV clinical trials, non-interventional trials, post-registration safety studies.
3 reasons to choose us
01.
Planning
Successful experience in the implementation of dozens of scientific projects allows us to calculate in advance all the parameters of the project and its timing. We do not take on a project if we are not sure that we will do it with high quality and within the stated time.
02.
Quality
High quality of documents preparation will reduce the number of requests from the regulator
03.
Transparency
All project activities are documented and summarized in a convenient format. This reduces the time for checks.
Contacts
+7-985-430-90-70
