We offers end-to-end pharmacovigilance solutions for products at the pre, peri and post-marketing stages of their lifecycle
Quality Management & Auditing
We have experience on pharmacovigilance audit. We help our clients with inspection readiness, post-inspection assistance, and routine pharmacovigilance audits.
From initial concept to authorisation, our regulatory team can assist with your initial regulatory strategy, dossier compilation and eCTD publishing needs.
Our company anticipates the changes related to EudraVigilance and the mastery of associated IT tools such as switching to E2B R3 format, EudraVigilance submissions and EVDAS.