Development of an Offshore Lifecycle Management Platform for Regulatory Information Services

The client faces resource constraints that hinder support for existing products and impede rapid development of new offerings. Lack of technical documentation and experience in managing remote teams has led to inefficiencies and distrust in offshore collaborations, resulting in failed vendor engagements and operational bottlenecks.

A mid-sized pharmaceutical technology company specializing in regulatory information services seeking to enhance product lifecycle management and offshore development capabilities.

• Improve development processes to support the extension of product portfolios and establish a sustainable business model.
• Enable successful management and delivery of core products through optimized workflows.
• Facilitate effective collaboration with offshore teams to accelerate development timelines.
• Reduce dependency on internal resources by establishing reliable remote team operations.
• Enhance product support and development capabilities to sustain industry leadership.

• A centralized submission management system to handle product lifecycle stages and compliance workflows.
• A comprehensive knowledge base consolidating client-specific information, documentation, and historical data.
• Process documentation tools to define, update, and share SDLC procedures tailored for remote and distributed teams.
• Role-based access control to manage knowledge transfer sessions and technical documentation sharing.
• Collaboration modules supporting real-time communication and task management across global teams.
• Integration interfaces to connect with existing enterprise systems and support automation.

• Enterprise documentation repositories
• Client’s existing product management and compliance systems
• Knowledge sharing portals

• Platform must support scalability to accommodate growth involving up to 100+ remote engineers.
• High availability with 99.9% uptime to ensure continuous product support.
• Security protocols compliant with industry standards to protect confidential compliance data.
• Performance benchmarks to handle complex workflows with minimal latency.

The implementation of the offshore lifecycle management platform is expected to significantly enhance product support and development efficiency, leading to the extension of product portfolios and sustainable business growth. The client anticipates improved collaboration, reduced cycle times, and support for a team of over 100 specialists, ultimately strengthening industry leadership and enabling successful corporate acquisitions.