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A preliminary gap assessment is a proactive review of your existing safety and regulatory documentation against the requirements and expectations relevant to your submission or regulatory pathway.
For organizations preparing for regulatory submissions such as a Generally Recognized as Safe (GRAS) determination or New Dietary Ingredient Notification (NDIN), incomplete, inconsistent, or insufficiently supported documentation can create questions, delays, additional requests, or other challenges during the review process.
Our preliminary gap assessment helps identify these potential issues before submission, giving you an opportunity to address them early.
What does a preliminary gap assessment involve?
We review your available documentation to identify areas that may be incomplete, inconsistent, unclear, or insufficiently supported for the intended regulatory purpose.
Depending on your project, the assessment may include a review of:
- Identity, specifications, and characterization information
- Manufacturing and quality documentation
- Scientific literature and references
- Regulatory history and supporting rationale
- Review existing safety and toxicology data
The assessment is tailored to the requirements and objectives of your specific project.
Why does it matter?
Regulatory submissions are evaluated based on the quality, completeness, consistency, and adequacy of the information provided.
A gap in your documentation may not necessarily mean that the ingredient presents a safety concern. However, if the available evidence does not adequately support the conclusions being made, it can create uncertainty during regulatory review.
A preliminary gap assessment helps you identify and address those issues proactively.
Reduce surprises
Identify potential documentation deficiencies before they are raised during regulatory review.
Strengthen your submission
Ensure that the available evidence and supporting documentation provide a clear and coherent basis for your safety conclusions.
Identify missing information
Highlight areas where additional data, references, clarification, or documentation may be needed.
Improve consistency
Identify discrepancies or inconsistencies between different documents, studies, data sources, and safety conclusions.
Prioritize next steps
Understand which gaps may require immediate attention and which can be addressed through clarification or additional supporting documentation.
What you receive
Following the assessment, you receive a clear summary of the identified gaps and areas requiring further consideration. Where appropriate, findings can be prioritized according to their potential significance to the intended regulatory submission, helping you focus resources where they are most needed. The outcome is a practical roadmap for strengthening your documentation before moving forward.
Be prepared before submission.
A preliminary gap assessment provides an opportunity to identify potential weaknesses before they become regulatory questions. By reviewing your safety and regulatory documentation early, you can strengthen the supporting evidence, address missing information, improve consistency, and approach your submission with greater confidence.
Know what you have. Identify what is missing. Address the gaps before submission.