One discipline, applied where regulated data actually drifts.
Each page below is the same workflow — approved source, expected surfaces, deterministic comparison, reviewer queue, closure evidence — applied to a specific regulatory object or situation. Every one of them lands in a Portfolio Integrity Scan or a Regulatory Change Integrity Review.
EUDAMED & UDI data
Registered device and actor records against controlled sources: field-level reconciliation, identifier structure, transition registration workload.
SS(C)P operations
Master, revision, translation and publication state held consistent with the technical documentation and the public record.
Class III / implantable MDR transition
Portfolio mapping, timing, evidence gaps and accountable review for the highest-stakes transition workload.
Authorised-representative portfolios
Reconciliation infrastructure for ARs and specialist consultancies managing many manufacturers: triage records, detect missing evidence, produce portable evidence packets. Your team makes the regulatory judgement.
Controlled document consistency
The same fact held consistent across DoC, label, IFU, technical file summary and registration data — and change propagation between them.
Language-version integrity & Danish linguistic validation
The approved fact held consistent across every maintained language version of labels, IFUs and SS(C)P translations, with medically literate Danish↔English review as the deepest capability.
Denmark market access & Danish PV
Danish authority mapping, market-specific evidence, controlled localisation and Danish pharmacovigilance support — the Danish-market entry to the same discipline.
Regulatory change impact
When a regulation or guidance changes: which document and data surfaces are touched, in what order, with what evidence to capture.
Sanitized specimens
Inspect the working method on fictional data before bringing your own: specimen register and portfolio work-plan sample.