OUR SERVICES
ANO “National Scientific Center for Pharmacovigilance” provides a full range of services for pharmacovigilance (monitoring the effectiveness and safety) of drugs, veterinary drugs, medical devices, user testing.
One of the most popular solutions. More than 50% savings compared to self-organization. Savings on wages, tax deductions, payments, etc.
Our specialists have prepared more than 1,500 periodic reports (PSURs and DSURs). Experienced medical writers, peer reviewing, and continual process improvement.
Detailed and brief description of the pharmacovigilance system, standard operating procedures, and the service of providing contact persons in countries of presence.
Weekly monitoring of literature and regulatory decisions is defined in pharmacovigilance legislation. We use our own how-tos.
Risks are inherent in all medicines and medical devices. Risks are not to be feared, they are effectively managed.
Described in Section IV of the Rules of Good Pharmacovigilance Practice is an essential element of a quality system of pharmacovigilance.
User testing is the testing of an insert sheet to examine the readability, clarity, and accessibility of the package information leaflet by target patient groups.
Includes: preparation of drug samples for registration review, writing sections 2,4-2,7 of the registration dossier, variations to the registered documents.
– medicinal product authorization
– registration of a pharmaceutical substance as part of the authorization of a finished drug;
– registration of a substance, which is supplied for sale to several plants for further production of finished drugs
– dietary supplements authorization
Consulting on the dossier preparation If necessary, review and revision of documents.
This is part of a clinical trial, conducted with human participants to compare the pharmacological properties (pharmacokinetics, pharmacodynamics, toxicity, etc.) of the generic and the reference drug.
Studies conducted to identify, characterize, or quantify safety hazards, confirm a drug’s safety profile, or evaluate the effectiveness of risk management measures
