Generating Regulatory Affairs Impact
Regulatory affairs organizations' limited resources are challenged to balance demands between maintaining the regulatory compliance of mature products with the need to achieve new product approvals. Success requires an operating model that leverages best-in-class, technology-enabled, standardized regulatory processes.
Genpact Pharmalink's lifecycle management services for mature products offer a holistic solution to solving capacity issues, maintaining global compliance, and extending product registrations.
Our solution is based on a unique Lean Digital approach that combines process excellence, advanced technology and Systems of Engagement (SoE), world-class analytics and deep regulatory expertise with an unbiased focus on what works for a sustainable technology enabled transformation of lifecycle management operations. This approach provides clients with high-quality services and best practices in regulatory affairs and safety, maximum efficiency, maximum visibility and performance analytics to trigger compliance actions. Our end-to-end solution portfolio in regulatory affairs and safety includes:
- License maintenance: Variations, annual reports, renewals, CPPs, labeling updates, change control evaluation, authoring, DMF maintenance, filing strategy, CDS
- Regulatory operations: Submission management, publishing (eCTD, Nees, paper), ancillary documents, archiving
- Emerging market submissions: Country-specific adaptation of core dossiers, completion of supporting documentation, agency meetings
- Regulatory information management: Database maintenance and updates, master data governance, XEVMPD/ISO IDMP maintenance, change control administration, correspondence tracking
- Compliance: Identifying and remediating compliance gaps, guaranteed and transparent maintenance of systems and databases
- Risk management/pharmacovigilance: QMS, literature search, aggregate reporting, signal detection, risk management. We deliver from our global centers of excellence located in key life sciences hubs, supported by expert transition management and change management services, proven in more than 5,000 projects.
A global pharmaceutical company reduced lifecycle management costs by 30% by implementing a scalable and flexible operating model across CMC document authoring, license renewals, and ancillary document support