EU Submissions

EU Product Information

ESM Portal unleashes the power of Intagras pharmaceutical product database. Companies that market pharmaceutical products in Europe must comply with the EMA guidance, under the European pharmacovigilance, requiring product data to be submitted in XEVMPD format (XML). ESM Portal allows your organization to create, manage, and store your product information in a database structure and allows your regulatory team to publish submissions in an efficient manner in the required XML format. ESM Portal provides an intuitive approach to importing EMA responses so that modifications and updates provided by EMA are automatically mapped to the source submission.
 
Find out how the power of ESM Portal can impact your organization in positive ways, and ensure you are always compliant with EMA regulations and guidelines under the European pharmacovigilance. Call (813) 226-1863 to schedule a demonstration.