End-to-end technical support for food manufacturers expanding into the US market—from validation to the FDA process.
As the KVS team, we provide support for process evaluation, on-site validation, expert reporting, FCE/SID process filing consultancy, and—when necessary—responding to technical inquiries from the FDA.
Field measurements and technical verification of the production process.
Technical evaluation of measurement and process data.
Technical expertise and filing support required for process filing.
Support throughout the process regarding requests for additional information and technical questions.
For acidified and low-acid hermetically sealed foods, the technical framework of the FDA process requires a comprehensive evaluation of the product, packaging, production equipment, process parameters, and studies demonstrating the reliability of the process.
We manage the entire process from a single point of contact—ranging from the generation of technical data in the field and validation to expert reports, and from FCE/SID filing support to responding to FDA technical inquiries.
We technically plan, execute, and follow every step—from your product process through the FDA filing stage.
The product, packaging, process, equipment, and existing documentation are reviewed.
The measurement and validation scope appropriate for the product and process is defined.
Required field measurements are performed and process data is collected.
The data is analyzed and the technical evaluation is documented in a report.
The technical information required for the filing is prepared and the filing process is supported.
When necessary, requests for additional information and technical questions are followed up.
The process values included in the FDA filing must represent the actual production conditions in the field. Therefore, the process is evaluated not only through set values, but also through measurement and technical assessment.
We support the preparation of technical information to be submitted to the FDA for the relevant product and process, the accurate filing of process data, and the technical follow-up of the process filing procedure.
Product, packaging, processing method, and critical parameters are compiled.
The consistency of filing data with the validation study and expert report is verified.
Field measurements and process information are not left as raw data; they are transformed into a traceable report structure that can be used during filing and technical evaluation.
Product, packaging, equipment, and process conditions are documented.
Field data is organized and prepared for analysis.
Critical process parameters and validation results are evaluated.
The evaluation, appendices, and traceability information are consolidated into a single report.
If the FDA requests additional clarification after process filing regarding the process, product, or submitted technical information, we support the technical assessment of the request and preparation of the required response.
Proceed with expert support from measurement and validation to the expert report, process filing, and FDA technical follow-up.
Product- and process-specific evaluations are performed for food manufacturers that export to the United States or are preparing to export and use thermal processing.
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