Regulatory Strategy & Product Classification

Validate the pathway before pricing the implementation.

A focused assessment establishes what the product is, whether the proposed route is viable and what must change before implementation can be scoped responsibly.

The practical issue

Companies often ask for an NPN filing, label review or reformulation quote before the governing product category is settled. If the classification, format or ingredients do not support that route, the estimate is built on a false premise.

Questions the assessment answers

The scope is built around the uncertainty that is preventing a defensible decision.

Is the product an NHP, conventional food, supplemented food, cosmetic or another category?
Is the format compatible with the intended pathway?
Are the ingredients, doses and claims viable?
What obligations follow from the classification?

What is reviewed

Depending on the project, Baseline may review formulations, proposed claims, directions, product format, existing labels, prior submissions and relevant Canadian requirements.

What you receive

A defined written assessment documents the findings, regulatory rationale, material constraints, available pathways and recommended next steps. It does not manufacture a viable path where none exists.

What happens next

Once the pathway is validated, Baseline can define the implementation work, responsibilities, dependencies and pricing. If reformulation or repositioning is required, that decision is made before further investment.

Start with the situation

Commit to the work the situation actually requires.

Discuss an Assessment