Pharmacovigilance

ESMAR provides a complete pharmacovigilance (PV) services, including review and verification of safety data obtained during the clinical trial, processing of individual reports on adverse events, preparation of individual reports for submission to the Health Authorities and investigators.
ESMAR has the knowledge, experience, infrastructure and effective communication chain to oversee all of your safety reporting requirements for the full life cycle of your products.
We offer you:
   -   Collection and maintenance of the reports related to the safety of the medical products and medical devices
   -   Maintenance of the database of all the received safety reports
   -   Translation and medical review of any safety reports and cover documents for submission to the regulatory authorities
   -   Preparation of the cover documents and submission of the reports related to the safety of the medical products to the regulatory authorities (Russia, Ukraine and other CIS countries)
   -    Writing of the Periodical Safety Reports of the medical product and submission to the regulatory authorities
   -    Periodical reporting to Sponsor
   -    Literary search of the safety reports related to the medical products
 
ESMAR helps you to demonstrate accountability and transparency to the Health Authorities and public by communicating safety concerns in a timely and effective way.