Key Benefits

• Automated content lifecycle — Create, process, and manage business-critical content more efficiently, from early research and development through regulatory reporting.

• Global information sharing — Create virtual, collaborative environments to enable people across departments and countries to manage regulatory approvals for products in multiple markets.

• Regulated content — Maintain audit trails for protocols, clinical documentation, study reports, submissions, standard operating procedures, product specifications, and marketing collateral.

• Regulatory submissions — Create, assemble, review, publish, and archive electronic submissions in compliance with regulations and global eCTD standards.

• Quality management — Maintain complete and validated records, including standard operating procedures (SOPs), quality specifications, test methods and protocols, and change management.

• Promotional traffic and marketing — Speed creation and distribution of brand-consistent ads, medical literature, promotional materials, web content, and sales materials.

• Records management and archiving — Implement long-term classification, declaration, retention, and disposition procedures for records and e-mail that meets compliance requirements.

• Regulatory portals — Automate processes for creating, managing, and publishing content to clinical trials, regulatory affairs, and consumer portals in multiple locations.