FSO
Removing a single-source dependency without changing the filing
Added a second source for a critical intermediate without disturbing the registered position.
Read the outlineSupply · Licensing · Market Access
One accountable partner from supply to market
We own the program end to end — qualified supply, registration, and market entry.
1100+
Partners
3700+
Projects
330+
Supplier Audits
23+
Years Experience
The problem
The failure is coordination, not chemistry
When five vendors each own a slice, nobody owns the outcome.
The usual arrangement
Five vendors, and you are the integrator
- Select and contract the manufacturer
- Commission audits separately
- Retain regulatory and process specialists ad hoc
- Escalate across parties when something slips
The FSO model
One responsible party, and you are the client
- One agreement for the whole program
- Audits and findings closed inside the program
- Route, impurity and documentation under one team
- One escalation point that owns the outcome
What we do
Two business lines, one operating principle
One party accountable end to end — whether material or a licensed asset.
Business line 01
API & Intermediates
Delivered as a program, not a purchase order
- FSO — sourcing to delivery under one contract
- FSO+ — registration, tech transfer and logistics
- Audits and documentation owned inside the program
Business line 02
Licensing & Market Access
Matched on evidence, planned for reimbursement
- Evidence matrices behind every shortlist
- Filing routes matched to your territories
- HTA screen before the term sheet
The model
Five coordination functions, one responsible entity
One party holds the plan and answers for the result — not five specialists you glue together.
Single Responsible Entity
Unibest
One contract. One plan. One escalation.
01
Supplier Network
Screening and commercial terms
01
Supplier Network
Screening and commercial terms
02
Audit & Qualification
On-site audit and CAPA closure
02
Audit & Qualification
On-site audit and CAPA closure
03
Logistics & Trade
Export, customs and delivery
03
Logistics & Trade
Export, customs and delivery
04
Process & Technical
Route, impurity and scale-up
04
Process & Technical
Route, impurity and scale-up
05
Regulatory Advisory
DMF, CEP and filing docs
05
Regulatory Advisory
DMF, CEP and filing docs
What powers it
The capabilities behind the recommendation
Not standalone products — the reason our answers are derived, not asserted.
How programs run
Structure, not testimonials
Anonymised outlines of how engagements were set up — and what actually made the difference.
FSO
Catching documentation drift before an inspection did
A baseline review caught documentation drift while the gaps were still cheap to close.
Read the outlineNeed detail on a situation like yours? Ask — we can go further in conversation.
All outlinesTell us what you are trying to source, register or license
Send the molecule or asset, the target market and the timeline. You will get a considered view of feasibility and the approach we would recommend — not a brochure.
Why Us
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One-Stop Solution
Unified Access: Your single gateway to a full spectrum of assets, from APIs and intermediates to strategic licensing.
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One-Stop Solution, slide 1 of 6
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