Since Pharmacovigilance origination in the early 1960s, the focus has not wavered in its efforts to make sure drugs and drug manufacturers take every precaution to make sure new medicines are safe and secure and produce the results intended without harmful effects to patients.
Developments in scientific research and treatment has vastly increased the complexity and need to coordinate the management of information regarding drug development, quality, safety and trials of emerging medicines. Although there has been movement to consolidate and develop common approach and terminology, the issues around the formation of submission documentation is compounded by the various regulatory agencies’ requirements for how information is reported.
Ennov5 is the right product to deliver on your Pharmacovigilance requirements. It provides either standardized templates or self designed templates to manage classification, creation, review, submission and maintenance of ICSR, PSUR and SUSAR reports to adhere to the EMEA, and FDA regulatory agencies.
Ennov delivers on lowering the costs and making it easier for companies to comply with pharmacovigilance requirements.