Product-specific role assessment
Assess intended use, product class and whether the role is feasible. Client-facing output: Responsibility matrix.
Clinical trial logistics
Medical Importer of Records
Medical Importer of Record service: a defined, documented Turkish legal party for the import transaction with explicit authority, responsibility and recor…
IMPinvestigational product
IVDkits and reagents
MDmedical devices
End-to-endoperating model
Importer accountability
Define authority, responsibility and record ownership early
Authorisation and party-data coordination
Align sponsor, manufacturer, shipper, seller, consignee and customs parties. Client-facing output: Authorisation file.
Customs and permit tracking
Verify agreements, powers and transaction authority. Client-facing output: Import transaction records.
Transaction record retention
Assign technical, conformity, permit, invoice and record duties. Client-facing output: Close-out archive.
Client-anonymized operating experience
The operating scope of past projects
Client names remain private; vaccine studies are shown by name with their own project figures.
International routes · Urgent coordination
Urgent international product shipments
Project scope6 routes · 28–35 hours from origin to destination
Past shipment summaries originating in New Delhi, London, Beijing, New York, Hong Kong and Shanghai cover cell-therapy material, research medicines, kits and consumables. The recorded times run from origin to destination; they are not customs-clearance durations.
For sponsors: For an urgent request, share product class, permit status, origin and target delivery time on one timeline.
Customs coordinationSource: past project summaries supplied by Omega. Quantities and times describe only the relevant historical examples, not current capacity or a delivery commitment. The source does not distinguish vaccine doses from vials.
Short answer
What does this service actually solve?
Importer of Record services document which Turkish legal party runs the import and who retains permit, customs, invoice, record and product-conformity duties.
Procurement brief
Medical Importer of Records
The Importer of Record model makes the accountable importing party and document ownership explicit.
Included in scope
- Product-specific role assessment
- Authorisation and party-data coordination
- Customs and permit tracking
- Transaction record retention
Outside scope
- Taking over manufacturer conformity duties
- Taking over sponsor clinical duties
- Automatic coverage of products outside written scope
Inputs we need
- Product and intended use
- Authorisations and agreements
- Value, quantity and shipment frequency
- Permit and conformity evidence
Records delivered
- Responsibility matrix
- Authorisation file
- Import transaction records
- Close-out archive
Risks affecting timing
- Unclear economic-operator roles
- Party mismatch across invoices and records
- Scope changes during the project
RACI
Decision and record ownership
Sponsor/CROStudy purpose, product scope, authorisation and clinical duties
ManufacturerConformity, technical file, labels and manufacturer declarations
Omega DepotAccepted local importer transaction and operational records
Customs brokerDeclaration, tariff and customs formalities
Exception scenarios
Keep control when the plan changes
Product scope changes
Do not add it automatically; repeat role and document assessment.
Invoice consignee conflicts with agreement
Correct commercial and customs parties before dispatch.
Manufacturer evidence is missing or expired
Do not assume manufacturer duties; hold until evidence is complete.
Operating model
From uncertainty to a traceable outcome
Every project follows the same control logic, adapted to product and protocol requirements.
- 01
Product and role screen
Assess intended use, product class and whether the role is feasible.
- 02
Party map
Align sponsor, manufacturer, shipper, seller, consignee and customs parties.
- 03
Authority file
Verify agreements, powers and transaction authority.
- 04
Document ownership
Assign technical, conformity, permit, invoice and record duties.
- 05
Transaction control
Operate only for products and shipments inside written scope.
- 06
Record closure
Close declaration, delivery, cost and retention obligations.
Service-specific FAQ
What to know before scoping
Does IOR transfer every conformity duty?
No. Manufacturer, sponsor and economic-operator duties remain separately governed.
Can Omega act as IOR for every product?
No. Product class, intended use, authority and documentation require screening.
Can work start without an agreement?
No importer transaction starts before written role and product scope.
Who receives the invoice?
The commercial and importer model is defined per project; there is no universal default.
How long are records retained?
Applicable legal and contractual periods are set in the project record plan.
Inside the facility
Real infrastructure, real operations
Omega Depot
Plan your next shipment with confidence
Share the product, route and timeline; our team will map a workable operational flow.