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Reengineering R&D Timelines and Tech Transfer Success for a Global Sterile Product Manufacturer

1. Challenge

This project was executed in collaboration with one of the Big Four consulting firms, where Origo acted as the Subject Matter Expert (SME).

The client, a prominent pharmaceutical company based in India is a global manufacturer of sterile injectable products. While they had an experienced R&D team and a robust Quality Assurance (QA) system, the company was grappling with two critical issues:

  • Extended product development timelines, often stretching to 30 months

  • High failure rates during technology transfer to production sites

Both issues were affecting cost, team morale, and speed to market.

2. Objectives

  • Diagnose reasons behind delays in product development and propose actionable solutions

  • Investigate tech transfer failures and revamp processes to improve success rates

  • Recommend systems that ensure speed without compromising compliance or quality

3. Our Approach

Diagnostic & Discovery

  • Requested the R&D and Project Management teams to generate Gantt charts for multiple development projects

  • Conducted in-depth interviews with key stakeholders in R&D, QA, Manufacturing, and Project Management

  • Reviewed projects that had either significantly delayed timelines or remarkable speed, and analyzed outliers to identify success/failure patterns

Process Reengineering

  • Mapped current processes end-to-end, identifying redundant checkpoints and bureaucratic loops

  • Identified missing linkages between formulation trials and manufacturing site readiness

  • Introduced a revised Tech Transfer SOP based on ISPE Guidelines

  • Conducted joint training sessions for R&D and Manufacturing teams to create shared ownership

4. Final Results

Impactful Transformation:

  • Proposed a new pathway to reduce development time from 30 months to 18 months, a 40% reduction

  • Revamped tech transfer SOP and implemented a cross-functional training program, addressing gaps that previously led to high failure rates

  • Projected outcome: faster time-to-market, reduced development costs, and improved morale and collaboration across teams

5. Key Learnings


  • Even in highly structured companies, systems can become too bureaucratic, unintentionally stifling innovation

  • Small overlooked inefficiencies can have compounding negative effects on output and speed

  • An external SME can offer fresh perspectives, cut through internal inertia, and drive actionable change

  • When the focus shifts from blame to improvement, every stakeholder wins

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