What Buyers Should Look For During Due Diligence When Purchasing a Pharma Asset
- Sarah Dittmann
- Sep 12
- 3 min read
When your company is considering licensing or acquiring a new drug compound, the science is only part of the story.
A compound might look promising in early studies, but hidden gaps in its development history can turn an exciting opportunity into a costly risk. That’s where a rigorous due diligence process comes in.
Due diligence isn’t just a checklist—it’s your chance to uncover red flags, validate claims, and make sure the asset you’re acquiring has a strong regulatory and clinical foundation. Here’s how to approach this process strategically.
🔍 The Key Areas to Review for Due Diligence
1. Non-Clinical Reports
Early-stage animal and in vitro studies set the tone for a compound’s safety profile. When reviewing these reports, focus on:
Compliance with Good Laboratory Practices (GLP).
The completeness and consistency of study reports.
Availability of raw data and supporting documentation.
Whether any pivotal non-clinical studies are missing or need updating.
Missing or poorly documented non-clinical data can create major delays down the road.
2. Literature Publications
Published research can validate or challenge claims about the compound. Look for:
Independent studies supporting safety or efficacy.
Publications highlighting competitors or potential risks.
Conflicting data that might influence regulatory submissions.
A comprehensive literature search is also part of a strong regulatory package, so any gaps here are worth noting.
3. Clinical Study Reports (CSRs)
Clinical studies provide the backbone of regulatory approval. During diligence:
Verify that CSRs are finalized and properly formatted.
Confirm that endpoints were clearly defined and met.
Check for inconsistencies in adverse event reporting.
Review any open or ongoing trials for potential future obligations.
4. Regulatory History Chronologies
Understanding a compound’s regulatory journey is critical. Review:
Submission timelines, including IND, NDA/BLA, and CTA filings.
Prior feedback from agencies like the FDA, EMA, or MHRA.
Any withdrawn or denied submissions.
Key decision points in the asset’s lifecycle.
A well-documented chronology gives you confidence that nothing important is being overlooked.
5. Regulatory Correspondence
Agency communications can reveal more than formal decisions. Ask for:
Meeting minutes and formal letters.
Requests for information (RFIs) or additional data.
Post-inspection correspondence and commitments.
The details here often highlight risks that don’t make it into the marketing pitch.
🚩 Red Flags to Watch For
Missing study reports or poorly documented data.
Gaps in regulatory submissions or unexplained delays.
Inconsistent numbering or archiving of critical documents.
No clear chain of correspondence with agencies.
🤝 How The Sugar Water Operations Team Can Help with Due Diligence
At The Sugar Water Operations Team, we specialize in operational and regulatory due diligence support for small and mid-sized biotech and pharma companies. We can:
Audit your potential acquisition’s data packages for completeness.
Create a complete catalog of what’s in a due diligence data room so you know exactly what you’re acquiring.
Build clear, accurate regulatory history chronologies.
Identify documentation gaps that could delay integration or filing timelines.
We’ll help you go beyond “check-the-box” diligence and make sure your team has a clear, actionable understanding of what you’re buying. Contact us to learn more or set up a quick chat.
💡 Takeaway
Diligence is more than a gatekeeping process—it’s your roadmap for making a smart investment. By reviewing the right documentation and leaning on experienced operations support, you can avoid surprises and position your acquisition for success.
