Regulatory Assessment and Gap Analysis
A structured review of your products and documentation against the regulations that apply to them, with a prioritised plan for closing the gaps.
A regulatory assessment is a structured review of what you currently have against what the applicable rules require. A gap analysis is the output: an ordered list of where you fall short and what closing each gap involves.
What it is
A regulatory assessment is a structured review of what you currently have against what the applicable rules require. A gap analysis is the output: an ordered list of where you fall short and what closing each gap involves.
Who needs it
Companies that hold documentation they cannot verify, that inherited a portfolio through acquisition or a supplier change, that have been challenged by a customer or an authority, or that want to know their exposure before an audit rather than during one.
The problem it solves
Most companies do not know whether their documentation is correct. Safety data sheets are frequently inherited from suppliers, prepared for a different market, or left unrevised after a reformulation. The document exists, so the obligation feels met. An assessment establishes whether it actually is.
What we assess
Whether your classification is correct for the applicable framework. Whether your safety data sheets are complete, current and in the required format for their market. Whether your labels carry the required elements. Whether the documentation matches the formulation as it stands today. Whether obligations exist that you are not currently meeting.
What you provide
Your current safety data sheets and labels, the formulations they relate to, and the markets each product is sold into.
What you receive
A findings document listing each gap, the requirement it relates to, the risk it carries, and what closing it involves, ordered by priority so you can work through it in a sensible sequence rather than all at once.
What happens next
You can close the gaps yourself using the findings, or we can do the remediation work. The assessment is written to be actionable either way.
Frequently asked questions
How do I know if my safety data sheet is compliant?
The common failure points are classification that does not match the current formulation, a format that does not meet the requirements of the market the document is used in, missing or outdated sections, and language that does not meet local requirements. A review checks each of these against the applicable framework.
What is a compliance gap analysis?
A comparison between your current documentation and practice and what the applicable regulations require, producing an ordered list of the differences and what it takes to resolve them.
We inherited safety data sheets from our supplier. Are they ours to rely on?
Responsibility depends on your role in the supply chain and the market. In several markets the company placing the product on the market carries obligations of its own regardless of who prepared the document. This is one of the most common areas where companies are exposed without knowing it.
What happens if the assessment finds significant problems?
We tell you plainly, prioritise the findings by risk, and set out what remediation involves. We would rather deliver an uncomfortable assessment than a reassuring one that does not hold.
Know your exposure before an audit
Send us your current documentation and the markets each product is sold into. We will tell you where you stand and what closing the gaps involves.