Engagement Model
FSO+
Qualified material is necessary but not sufficient. FSO+ extends the same single-accountability model across the registration and technology-transfer work that stands between a molecule and a market.
Overview
Where FSO stops and FSO+ continues
An FSO program delivers qualified material against a specification. That is enough when the buyer already holds the marketing authorisation and simply needs a reliable, well-documented supply chain.
It is not enough when the market itself is new. Entering a regulated territory means selecting a filing pathway, assembling a dossier that the authority will accept, mapping supplier documentation into that dossier, and often moving a process between sites so it can be manufactured at the required scale and standard.
FSO+ keeps the single-accountability structure and extends it across those activities. The same party that qualified the manufacturer is responsible for making sure the manufacturer's documentation supports the filing — which removes the most common failure mode in market entry, where the supply chain and the regulatory workstream are managed by parties that never speak to each other.
Filing pathway chosen deliberately
Centralised, decentralised, mutual recognition or national — the route is selected against your target countries, timeline and budget rather than by default.
Supplier documentation mapped to the dossier
The DMF, method validation and stability data are reviewed against what the filing actually requires, before submission rather than in response to a deficiency letter.
Technology transfer handled as a project
Where a site change or scale-up is required, the process package, analytical methods and validation strategy move together under one plan.
One party accountable across both workstreams
Supply and registration are run against a single program plan, so a change on one side is assessed against the other immediately.
Scope
What FSO+ adds
FSO+ includes the complete FSO scope. The modules below are the extension; they are configured to the target market and the maturity of the asset.
Regulatory & Market Entry
- Filing pathway assessment across target territories
- Dossier gap analysis against the chosen pathway
- CTD module preparation and compilation support
- Response drafting for authority questions and deficiency letters
- Local representative and agent coordination where required
Technology Transfer
- Process package assembly and receiving-site assessment
- Analytical method transfer and comparability
- Scale-up and engineering batch planning
- Validation strategy and protocol review
- Post-transfer performance monitoring
Cross-Border Execution
- Import licence and permit coordination
- Customs classification and tariff assessment
- Controlled and hazardous goods handling
- Serialisation and market-specific labelling requirements
- In-market storage and distribution coordination
Accountability
Where the boundary sits
FSO+ shifts more of the market-entry work to Unibest, but ownership of the marketing authorisation and the commercial decision stays with you.
| Activity | Your team | Unibest |
|---|---|---|
| Market selection | Decides which territories to enter and in what order | Provides pathway, timeline and documentation-burden assessment per territory to inform that decision |
| Filing pathway | Approves the recommended route | Assesses centralised, decentralised, mutual recognition and national options against your timeline and portfolio |
| Dossier | Owns the submission and the marketing authorisation | Performs gap analysis, compiles supplier-side modules and drafts responses to authority questions |
| Technology transfer | Approves the receiving site and the validation strategy | Runs the transfer project — process package, method transfer, engineering batches, validation support |
| Supply | Provides forecast and purchase orders | Full FSO scope: sourcing, audit, quality oversight, documentation and delivery |
| In-market logistics | Nominates the receiving entity | Coordinates import permits, customs, market-specific labelling and onward distribution |
Market selection
Your team
Decides which territories to enter and in what order
Unibest
Provides pathway, timeline and documentation-burden assessment per territory to inform that decision
Filing pathway
Your team
Approves the recommended route
Unibest
Assesses centralised, decentralised, mutual recognition and national options against your timeline and portfolio
Dossier
Your team
Owns the submission and the marketing authorisation
Unibest
Performs gap analysis, compiles supplier-side modules and drafts responses to authority questions
Technology transfer
Your team
Approves the receiving site and the validation strategy
Unibest
Runs the transfer project — process package, method transfer, engineering batches, validation support
Supply
Your team
Provides forecast and purchase orders
Unibest
Full FSO scope: sourcing, audit, quality oversight, documentation and delivery
In-market logistics
Your team
Nominates the receiving entity
Unibest
Coordinates import permits, customs, market-specific labelling and onward distribution
Process
How an FSO+ program is run
The supply and regulatory workstreams run in parallel against one plan, with defined points where each must confirm the other before the program advances.
- 01
Market & pathway assessment
Target territories are assessed for filing route, documentation burden, expected timeline and the evidence the authority will require. The output is a route recommendation with the trade-offs made explicit.
- 02
Dossier gap analysis
Existing documentation is reviewed against what the chosen pathway requires. Gaps are classified by whether they need new data, new studies or only reformatting — which is what actually determines the timeline.
- 03
Supply chain qualification
The full FSO qualification runs in parallel, with the additional constraint that the manufacturer's documentation must support the filing, not merely satisfy a purchase specification.
- 04
Technology transfer
Where a site change or scale-up is needed, the process package and analytical methods are transferred, engineering batches are run, and validation is completed against the agreed protocol.
- 05
Submission & authority interaction
The dossier is compiled and submitted through the agreed route. Questions and deficiency letters are answered against a tracked response plan rather than ad hoc.
- 06
Launch & lifecycle
On approval, supply moves to commercial cadence. Variations, change notifications and re-qualification are managed as ongoing obligations under the same program.
Comparison
What changes when you move from FSO to FSO+
FSO+ contains the whole FSO scope. The rows below are the ones where the two models actually differ — everything else is identical.
| Dimension | Conventional trading | FSO | FSO+ |
|---|---|---|---|
| Supply chain qualification | Your team | Included | Included |
| Filing pathway selection | Not included | Not included | Assessed across CP, DCP, MRP and national routes |
| Dossier preparation | Not included | Not included | Gap analysis, CTD compilation and response drafting |
| Authority interaction | Not included | Not included | Questions and deficiency letters handled on a tracked plan |
| Technology transfer | Not included | Not included | Process package, method transfer and validation support |
| Cross-border execution | Freight only | Export documentation and delivery | Import permits, labelling and in-market distribution |
| Who holds the marketing authorisation | You | You | You |
Supply chain qualification
- Conventional trading
- Your team
- FSO
- Included
- FSO+
- Included
Filing pathway selection
- Conventional trading
- Not included
- FSO
- Not included
- FSO+
- Assessed across CP, DCP, MRP and national routes
Dossier preparation
- Conventional trading
- Not included
- FSO
- Not included
- FSO+
- Gap analysis, CTD compilation and response drafting
Authority interaction
- Conventional trading
- Not included
- FSO
- Not included
- FSO+
- Questions and deficiency letters handled on a tracked plan
Technology transfer
- Conventional trading
- Not included
- FSO
- Not included
- FSO+
- Process package, method transfer and validation support
Cross-border execution
- Conventional trading
- Freight only
- FSO
- Export documentation and delivery
- FSO+
- Import permits, labelling and in-market distribution
Who holds the marketing authorisation
- Conventional trading
- You
- FSO
- You
- FSO+
- You
Fit
When FSO+ is the right model
FSO+ carries more scope and more coordination than FSO. It is warranted when the destination market is the hard part of the problem.
You are entering a market for the first time
There is no existing marketing authorisation and the filing pathway itself is a decision with cost and timeline consequences.
The process must move sites
Scale-up, a capacity change or a supply-security decision requires the process to be transferred without losing comparability.
Your regulatory function is at capacity
The filing is competing for internal resource against higher-priority programs and needs external ownership to move.
Supply and regulatory keep diverging
A previous program stalled because the supplier documentation did not match what the dossier assumed.
Questions
Frequently asked
No. The marketing authorisation is yours. We prepare, compile and support the submission and respond to authority questions, but the holder and the commercial decisions remain with you.
Start with a pathway assessment
Tell us the asset and the territories you are targeting. We will come back with the filing routes worth considering and what each would require.
Related
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