Clinical trial logistics

Import Licence

Import License We provide import license submission procedures to MoH. Our depot is also 8 km (5 miles) to MoH. With these location advantage, we…

Discuss your projectRegulatory intelligence
IMPinvestigational product
IVDkits and reagents
MDmedical devices
End-to-endoperating model

Permit readiness

Keep the application dossier and shipment data aligned

01

Product, manufacturer, study and quantity pre-check

Confirm intended use, study role and parties. Client-facing output: Application checklist.

02

Application dossier preparation and authority-process coordination

Compare protocol, approval, product, manufacturer and quantity. Client-facing output: Submission record.

03

Permit, invoice and shipment-data alignment

Identify missing or conflicting documents before booking. Client-facing output: Permit or outcome document.

04

Application and outcome record filing

Compile controlled versions and authorisations. Client-facing output: Shipment-readiness notice.

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 coordination

Source: 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?

Import licensing aligns approved study data with product, manufacturer, quantity and shipment documents before entry into Türkiye.

Procurement brief

Import Licence

Import licensing connects the approved study and product data to the shipment dossier.

Included in scope

  • Product, manufacturer, study and quantity pre-check
  • Application dossier preparation and authority-process coordination
  • Permit, invoice and shipment-data alignment
  • Application and outcome record filing

Outside scope

  • Binding tariff classification
  • Creation of sponsor scientific documents
  • Guaranteeing an authority decision
01

Inputs we need

  • Approval reference and protocol
  • Product and quantity list
  • Manufacturer, shipper and consignee details
  • Planned value and dispatch date
02

Records delivered

  • Application checklist
  • Submission record
  • Permit or outcome document
  • Shipment-readiness notice
03

Risks affecting timing

  • Mismatch with the approved dossier
  • Document changes before dispatch
  • Booking transport before the outcome

RACI

Decision and record ownership

Sponsor/CROApproved study data, scientific documents and change notices
Shipper/manufacturerCurrent product, manufacturer, invoice, packing and dispatch data
Omega DepotPre-check, dossier coordination, submission record and shipment alignment
AuthorityAssessment, information requests and formal decision

Exception scenarios

Keep control when the plan changes

Product or quantity differs from approval

Hold dispatch while the sponsor assesses an amendment or new application.

Invoice changed after application

Recheck affected fields and reconcile the dossier.

Shipment is urgent

Do not guarantee timing; document dependencies and risks.

Operating model

From uncertainty to a traceable outcome

Every project follows the same control logic, adapted to product and protocol requirements.

  1. 01

    Scope classification

    Confirm intended use, study role and parties.

  2. 02

    Approval alignment

    Compare protocol, approval, product, manufacturer and quantity.

  3. 03

    Gap analysis

    Identify missing or conflicting documents before booking.

  4. 04

    Application assembly

    Compile controlled versions and authorisations.

  5. 05

    Outcome follow-up

    Assign authority questions to the correct owner.

  6. 06

    Shipment gate

    Reconcile the outcome against invoice, packing and transport data.

Service-specific FAQ

What to know before scoping

Can transport be confirmed before permission?

A provisional booking may be possible, but movement should not be confirmed before permission and shipment data reconcile.

Can one permission cover several shipments?

Review wording, quantity, product and validity; never assume automatic reuse.

Does a manufacturer change matter?

Yes. Manufacturer identity is a core approval and application field.

Does Omega create scientific documents?

Omega coordinates the operational dossier; it does not author sponsor or manufacturer scientific evidence.

How is timing estimated?

A project schedule follows review of completeness, scope, authority questions and likely changes.

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.

Talk to our team