Your agency reporting requirements + our pharmacovigilance expertise
No matter what part of the drug development cycle you are in, you need to keep a sharp eye on the way your safety data is collected and reported. Envigo employs a specialized pharmacovigilance group committed to supporting the set up and management of your PV reporting system and to ensuring you meet agency reporting requirements.
We deliver pharmacovigilance support in both clinical and peri- / post-marketing settings, and we have the necessary experience to assume the role of responsible person for eudraVigilance and qualified person for pharmacovigilance.
With extensive changes currently occurring within the pharmacovigilance legislation and regulations, we are well positioned to navigate you through the requirements for post-marketing pharmacovigilance, including preparation and maintenance of the pharmacovigilance system master file.