Regulatory Services
Compliance support for manufacturers and trading businesses, from first technical file to post-market monitoring.
How a regulatory engagement runs
Every project follows the same five steps, so you always know what has been checked and what is still open.
Scope and classification
We confirm which regulations, standards and markets apply to the product and record the classification in writing.
Gap review
Drawings, test reports, labels and instructions are compared line by line against the requirements.
Technical file
We assemble or update the technical documentation and declarations, with references you can audit later.
Assessment liaison
We prepare the submission, answer assessor questions and track corrective actions to closure.
Monitoring
Standards and guidance change. We review your file on a fixed schedule and flag anything that needs action.
What we check
Regulatory work is mostly detail. We look at the parts of a file that tend to fail first.
- Applicable directives and national rules for each market
- Declared standards and whether the cited editions are current
- Test reports matched to the exact product configuration
- Labelling, warnings and instructions in the required languages
- Traceability from design changes to the documentation
Working with your team
We work inside your existing process. Design and quality staff keep ownership of the product; we provide the regulatory reading and the file structure.
Site records
Recent work on compliance files, shown as it was carried out.
Common questions
We prepare the evidence and declaration. The manufacturer signs the declaration and affixes the mark.
Yes. An existing file is the usual starting point for a gap review, and we report findings before any rework.
A single-product gap review is usually completed within two to three weeks of receiving complete documents.
The gap review found three labelling errors we had missed for two years. The file was in order before the assessor arrived.
Electrical equipment manufacturer
To discuss a product or market, return to the home page or read about our expertise.