Solutions

Programs, not purchase orders

Sourcing a molecule is a transaction. Keeping it qualified, documented, registered and available is a program. We contract for the program and stay accountable for it.

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How engagements are structured

Choose the level of accountability you need

Every engagement is built from the same modules. What differs is how many of them you keep in-house and how many you transfer, together with the accountability that goes with them.

FSO and FSO+ are the two complete engagement models. The remaining modules can be taken individually where you already have the rest of the capability in place.

One accountable owner for your supply program

FSO — Full Service Outsourcing

Instead of contracting a manufacturer, an auditor, a regulatory consultant and a freight forwarder separately, you contract one party that coordinates all of them and answers for the result.

SourcingSupplier AuditQuality OversightLogisticsSingle Contract

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Supply, plus registration and technology transfer

FSO+ — Extended Program

Everything in FSO, extended to the activities that decide whether the material can actually be sold in your target market: registration strategy, dossier support and technology transfer.

RegistrationTechnology TransferDossier SupportMarket EntryLogistics

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The model

What a single responsible entity actually coordinates

These five functions exist in every sourcing program. The only question is whether you hold them together yourself or transfer that job — and the accountability with it.

Single Responsible Entity

Unibest

One contract. One plan. One escalation.

Supplier Network

Screening and commercial terms

Supplier Network

Screening and commercial terms

Audit & Qualification

On-site audit and CAPA closure

Audit & Qualification

On-site audit and CAPA closure

Logistics & Trade

Export, customs and delivery

Logistics & Trade

Export, customs and delivery

Process & Technical

Route, impurity and scale-up

Process & Technical

Route, impurity and scale-up

Regulatory Advisory

DMF, CEP and filing docs

Regulatory Advisory

DMF, CEP and filing docs

Program modules

Take a module on its own

Where you already have most of the capability in place, individual modules can be scoped independently of a full FSO or FSO+ engagement.

The manufacturing base behind every program

API & Intermediate Supply

Direct access to qualified API, intermediate, excipient and custom-synthesis capacity — the supply foundation that FSO and FSO+ programs are built on.

APIsIntermediatesExcipients

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Moving a process without losing it

Technology Transfer

Process packages, analytical methods and validation strategy moved between sites as one project, so the receiving site reproduces the process rather than reinventing it.

Process TransferMethod TransferScale-Up

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Documentation kept current, not just collected

Regulatory & Quality Support

DMF and CEP tracking, audit readiness, change control and deviation handling maintained as ongoing obligations rather than one-off onboarding deliverables.

DMF / CEPAudit ReadinessChange Control

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Continuity planned before it is needed

Supply Chain Risk Management

Dependency mapping, second-source qualification and continuity planning, so a single site, a single route or a single certificate is never the thing that stops your supply.

Dual SourcingContinuity PlanningDependency Mapping

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Comparison

Three ways to buy the same molecule

The material can be identical in all three columns. What differs is how much integration work sits with your team and who is accountable when something moves.

Comparison of Conventional trading, FSO, FSO+ across 7 dimensions
Dimension	Conventional trading	FSO	FSO+
Number of counterparties you manage	Manufacturer, auditor, consultant, forwarder — separately	One	One
Who selects and qualifies the manufacturer	Your team	Unibest, against your approval	Unibest, against your approval
Supplier audit	You commission it separately	Commissioned and closed out within the program	Commissioned and closed out within the program
Quality documentation upkeep	Collected at onboarding	Tracked as a living program asset	Tracked and mapped to your filings
Regulatory filing support	Not included	Supplier-side documentation only	Filing strategy, dossier support and authority interaction
Technology transfer	Not included	Not included	Included where a site change or scale-up is required
Accountability when a batch slips	Distributed — often disputed	Single point of accountability	Single point of accountability

Number of counterparties you manage

Conventional trading: Manufacturer, auditor, consultant, forwarder — separately
FSO: One
FSO+: One

Who selects and qualifies the manufacturer

Conventional trading: Your team
FSO: Unibest, against your approval
FSO+: Unibest, against your approval

Supplier audit

Conventional trading: You commission it separately
FSO: Commissioned and closed out within the program
FSO+: Commissioned and closed out within the program

Quality documentation upkeep

Conventional trading: Collected at onboarding
FSO: Tracked as a living program asset
FSO+: Tracked and mapped to your filings

Regulatory filing support

Conventional trading: Not included
FSO: Supplier-side documentation only
FSO+: Filing strategy, dossier support and authority interaction

Technology transfer

Conventional trading: Not included
FSO: Not included
FSO+: Included where a site change or scale-up is required

Accountability when a batch slips

Conventional trading: Distributed — often disputed
FSO: Single point of accountability
FSO+: Single point of accountability

Not sure which model fits?

Describe the situation — the molecule, the market and what has gone wrong before. We will tell you which modules are worth taking and which you should keep in-house.

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