Gap Analysis: The Benefit of Conducting Technical and Regulatory Due Diligence

By Marites T. Woon (Associate Director, Nonclinical), Nick Sanich (Director, Business Development), Richard Stewart (VP, Nonclinical), William Lee (VP, Regulatory Affairs), and Marcus S. Delatte (VP, Regulatory Strategy)

Regulatory strategies are different for each product and should be designed specifically with the end objectives in mind. Regulatory due diligence helps to plan for regulatory requirements and avoid non-compliant practices from the start.  

An integral part of building a successful regulatory strategy is conducting a gap analysis.  

What is a gap analysis? 

A gap analysis is the process of evaluating an asset or product development program based on various types of technical or regulatory information, as well as critical documents and data. A thorough analysis includes a systematic review of information from both the public domain and the Sponsor, enabling manufacturers to identify and mitigate gaps before submission.  

A gap analysis may be targeted on one specific strategy, like nonclinical, or have a broad approach and encompass strategies across multiple disciplines – CMC, nonclinical, clinical, and regulatory affairs. 

What is included in the findings of a gap analysis? 

A gap analysis identifies any missing elements in your data package, uncovers limitations or risks to the success of an asset or development program, and leverages key insights from seasoned experts, in fields such as CMC, clinical (strategy and pharmacology) and nonclinical, to deliver comprehensive and well-integrated approaches to mitigate risks and keep a line of sight to key milestones. 

How do you use findings from a gap analysis? 

Gap analysis results alone may not yield many benefits, the critical piece is how you use the results. Companies can leverage findings from a gap analysis to optimize resource utilization, such as time and budget, as well as inform critical decisions in strategy development and implementation. Findings are also helpful in recommending optimal timing for studies and can ensure you get the most value out of your data moving forward. 

For example, after a careful and comprehensive assessment, it may be possible to mitigate costs and accelerate timelines by integrating safety pharmacology endpoints into a toxicology study rather than conducting multiple studies. Saving time often contributes to further cost savings when you consider the re-allocation of time toward value-added activities. 

Who should conduct a gap analysis? 

Conducting a gap analysis requires a depth of expertise and knowledge in many different areas. In order to anticipate your project’s unique needs, you need experts who have experience in regulatory submission strategy combined with a deep understanding of your product and are knowledgeable about all aspects of the project – scientific, technical, CMC, nonclinical, clinical, and regulatory affairs.  

It is important for these experts to collaborate with your team and use a unique and personalized approach for your project to create more effective and efficient strategies for every stage of product development. 

Why is conducting a gap analysis so important for small to mid-sized biotech companies? 

Careful planning with a gap analysis can help to avoid missteps that may render data inconclusive or require additional patient recruitment and studies. This is especially important for small to mid-sized biotech companies that need to take extra steps to preserve limited resources and ensure available funding through completion. 

At the end of the day, conducting a thorough and well-executed gap analysis and using its findings to inform strategy development results in identifying the best and most appropriate regulatory approach – one that balances risk, costs and speed to approval.  

Allucent has over 30 years of experience in regulatory processes and strategy development. Our expert A-team collaborates with you to design an approach that fits your needs and meets your objectives. Contact us to learn more.