Regulatory mapping
Target authority, product or facility classification, legal operator and evidence route are defined.
Infinity IVD leads
REGULATORY PATHWAY MANAGEMENT
Regulation is not a final obstacle. It is a managed project workstream.
Infinity IVD connects facility engineering, quality systems, technical documentation and local authority coordination from the first design decision—while every licence, certification and market-authorisation decision remains with the competent authority.
ACTIVE PROCESS MANAGEMENT
The facility and the approval pathway must be designed together.
A completed building cannot operate, and an installed production line cannot lawfully release product, until the applicable local requirements are satisfied. Infinity IVD therefore treats regulatory work as part of the project programme: mapping the route, preparing the contracted evidence, coordinating submissions, responding to deficiencies and aligning inspection readiness with commissioning.
Boundary: Infinity IVD manages and supports the agreed process. Certification, registration, licensing and market authorisation remain subject to the competent authority or conformity-assessment body.
Who does what—and when.
The sequence changes by jurisdiction and project type, but the responsibility boundary never remains implicit.
Dossier architecture
Technical, quality, validation, labelling, language and local administrative requirements are assembled.
Infinity IVD leadsSubmission & communication
The application calendar, authority questions, local representation and controlled correspondence are coordinated.
Infinity IVD managesGap closure & inspection
Deficiencies, corrective evidence, site readiness and inspection logistics are tracked to closure.
Infinity IVD coordinatesLicence or authorisation
The authority reviews evidence, performs any required inspection and issues its independent decision.
Authority decidesStart from an existing technical foundation—not from a blank product file.
Where an IVD joint venture and licence structure is legally and commercially appropriate, existing Infinity IVD technical documentation, product and process know-how, validation evidence and training assets can provide the starting basis for local production. Every use remains subject to the target market’s facility, legal-manufacturer, notification, registration and approval requirements.
STANDARD DEVELOPMENT ROUTENew product and evidence architecture
- Product development
- Performance evidence
- Technical file
- Local application
- Production release
INFINITY IVD JV ROUTEExisting controlled foundation + local adaptation
- JV / licence basis
- Technical file & know-how transfer
- Local gap assessment
- Facility and dossier adaptation
- Production release
The diagram shows a reduced development burden, not a guaranteed approval time. The actual route and duration depend on product classification, legal-manufacturer structure, local facility status, authority requirements and evidence acceptability.
Technical documentation
Contracted product, performance, risk and quality evidence selected for local gap assessment.
Product & process know-how
Controlled formulations, process parameters, QC logic and manufacturing instructions within the agreed licence.
Regulatory references
Existing approvals and certificates may support the route where the target authority accepts their relevance.
Training & competence
Role-based transfer, pilot production and evidence that the local operator can sustain the controlled process.
Process ownership is visible. Approval authority is separate.
| Workstream | Infinity IVD | Investor / JV partner | Local authority |
|---|---|---|---|
| Regulatory dossier preparation | Leads and coordinates | Provides legal and local data | Reviews |
| Authority process management | Tracks and responds | Supports local representation | Inspects and decides |
| JV technical file and know-how | Provides contracted assets | Implements local adaptation | Evaluates notification or application |
| Facility and QMS readiness | Designs and supports evidence | Operates and sustains compliance | Assesses where applicable |
| Final licence or certification | Does not issue approval | Does not issue approval | Sole decision authority |
One regulatory method does not fit every facility.
Hospitals & Clinical Facilities
- National facility construction and operating licence
- Clinical governance and department-specific requirements
- Medical gas, fire/life-safety and commissioning evidence
- Authority grants the operating licence; Infinity prepares contracted readiness outputs
- Infinity boundary
- Contracted gap assessment, facility/QMS planning, validation structure, dossier preparation and readiness support.
- Client / legal operator
- Truthful submissions, legal-manufacturer or operator obligations, staffing, operation and sustained compliance.
- Independent authority
- Inspection, certification, licence, registration and market-authorisation decisions.
TARGET COUNTRY + PROJECT STRUCTURE
Define the regulatory route before fixing the facility and JV scope.
The readiness review identifies the target authority, applicant structure, available evidence, local gaps, facility obligations and decision dependencies.