Introduction

Regulators aren’t just box-checkers. They’re scientists, risk evaluators, and guardians of public health. Understanding how they think about impurity data can help buyers and sellers prepare dossiers that sail through reviews.

What Regulators Look For

1. Completeness – Is every impurity identified, quantified, and justified?

2. Method validation – Are analytical methods reproducible and sensitive enough?

3. Justification of limits – Why is your proposed threshold scientifically sound?

4. Risk management – What’s your approach to mutagenic impurities?

5. Consistency – Are stability, batch, and process data aligned?

Common Red Flags for Regulators

• Uncharacterized peaks.

• Overreliance on literature without lab verification.

• Inconsistent impurity limits across documents.

• COAs that don’t match dossier claims.

How Buyers & Sellers Can Align Better

• Think like a regulator: assume they’ll question every assumption.

• Provide backup data proactively.

• Document everything with clarity and reproducibility.

How Impurityx Supports This

Impurityx connects buyers with sellers who provide detailed dossiers, validated methods, and transparent data. This helps ensure that when regulators review, they see completeness — not gaps.

Closing Thought

Approvals happen faster when you see data through a regulator’s eyes. Shift perspective, and compliance becomes a smoother journey.