Regulatory strategy.
Regulatory strategy support for in-vitro diagnostic products in the EU under IVDR, with adjacent-market planning for organisations preparing to expand.
What regulatory strategy is, and what it isn't.
Strategy and submission support — not approval. We help teams choose the right classification and pathway, structure the technical documentation, identify the gaps that will block a submission, and plan the work needed to close them. The work is intellectual, methodological, and document-heavy.
We do not promise regulatory outcomes — for our own products or for clients’ — and any consultant who does is selling something else. Regulators decide; consultants help teams arrive at the regulator’s desk with a coherent file. Cervixel itself is currently under CE marking review for RapidCan, and we know the difference between strategic support and a guarantee.
The point of an engagement is to remove avoidable risk from a submission and to surface unavoidable risk in writing, where it can be planned for.
Who benefits from regulatory strategy work.
IVD developers preparing CE marking
Manufacturers approaching IVDR submission and needing a defensible classification, pathway, and evidence plan.
Teams entering the EU
Organisations expanding into the EU market from another jurisdiction and mapping the regulatory delta against IVDR.
Mid-development pressure-tests
Companies in mid-development evaluating whether their evidence plan will hold up under regulator scrutiny before they commit further.
How a regulatory engagement runs.
Most regulatory engagements begin with a written gap analysis of the current evidence and documentation against the chosen pathway. From there, work follows the submission roadmap: technical-file structuring, evidence planning, and pre-submission documentation, with milestones agreed in writing before each phase begins. Where evidence is missing, we say so — and we tell you what would close the gap rather than papering over it.
Other ways we partner.
CRISPR assay development
Design and optimisation of Cas-based detection assays for nucleic-acid targets in clinical and research settings.
Molecular diagnostics consulting
Strategic guidance on assay architecture, sample workflows, and translation from concept to clinical use.
Clinical validation support
Study design, partner sourcing, and analytical-to-clinical performance evaluation for diagnostic candidates.
Contract research
Targeted laboratory work for biotech and pharmaceutical partners — flexible scope, rigorous documentation.
Global procurement services
Sourcing of medical devices, IVDs, and pharmaceuticals from European supply chains for international partners, with full audit and compliance documentation.
Pressure-test your regulatory plan.
If you’d rather find a hole in your plan now than during a regulator’s review, we should talk.