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Rapid Technical Due Diligence for a CDMO Investment -Empowering Informed PE Decisions

1. Challenge

This project was commissioned by a leading Private Equity (PE) firm exploring a significant investment in a Mumbai-based Contract Development and Manufacturing Organization (CDMO).

The assignment was to conduct a technical due diligence audit of the CDMO within an extremely tight timeline. Origo was brought in as the Subject Matter Expert (SME) to:

  • Visit the site

  • Assess the R&D, QA/QC, and production capabilities

  • Review documentation and infrastructure

  • Evaluate the pipeline, IP, and regulatory readiness

All of this had to be completed within a single day on-site, followed by a comprehensive report within the deadline to aid the PE firm's decision-making.

2. Objectives

• Evaluate R&D capability and pipeline deliverability

• Assess intellectual property (IP) landscape and assign commercial viability

• Review QA/QC readiness for US FDA and global compliance

• Estimate real production capacity across dosage forms based on manpower, equipment, and timelines

• Compile all findings into a weighted risk assessment framework to support investment decisions

3. Our Approach

Rapid On-Site Assessment 

• Reviewed product pipeline across development stages


• Applied a weighted average scoring model for technical maturity and market potential


• Evaluated IP status and alignment with global filings


• Audited QC systems, instrumentation, and staff competence


• Assessed QA systems against US FDA expectations


• Visited manufacturing areas and warehouse to estimate throughput and compliance


Risk Modeling & Reporting 

• Designed a visual scoring matrix based on capability, capacity, and compliance

• Compiled a detailed, decision-focused report tailored for non-technical investors

• Presented findings with actionable insights and investment implications



4. Final Results

• Delivered a comprehensive technical due diligence report within the tight timeline

• Identified both risks and strategic advantages of the target CDMO

• Enabled the PE firm to make a confident investment decision

• The firm proceeded to invest INR 150 crores in the CDMO based on Origo's assessment

5. Key Takeaways



• Even with time constraints, a structured technical framework enables meaningful due diligence

• Translating complex technical evaluations into actionable investment insights is key for financial stakeholders

• Collaborating with PE firms and banks requires balancing technical depth with business clarity

• Origo built strong capabilities in rapid diagnostics, investor communications, and IP + regulatory alignment


Talk to us about Pharma Due Diligence & Technical Audit Support





 
 
 

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