Engagement Model
Full Service Outsourcing
You define the molecule, the specification and the market. We take ownership of everything required to put qualified material on your dock — and remain the single point of accountability if anything moves.
Overview
Why a single responsible party changes the outcome
A conventional sourcing program forces the buyer to become a systems integrator. You find candidate manufacturers, commission an audit firm, retain a regulatory consultant to review the DMF, brief a process chemist on impurity questions, and appoint a forwarder for cross-border shipment. Each party is competent within its own scope and accountable for nothing outside it.
The gaps between those scopes are where programs fail. An audit finding that never reaches the process team. A specification change that never reaches the filing. A route change at the manufacturer that nobody maps to the registered starting material. These are coordination failures, not technical ones.
Full Service Outsourcing removes the integration burden from the buyer. Unibest contracts as one responsible entity, holds the relationships with every upstream party, and carries the obligation end to end. You manage one agreement, one point of escalation and one program plan.
One contract, one owner
A single agreement covers sourcing, qualification, quality oversight and delivery. There is no gap between vendors for a problem to fall into.
Audit findings feed the program
Supplier audits are commissioned and read by the same team that manages the supply plan, so findings translate into corrective actions and re-qualification schedules.
Documentation kept current
DMF status, CoA formats, impurity profiles and change notifications are tracked as living program assets, not one-off deliverables collected at onboarding.
Escalation goes to one desk
When a batch, a document or a shipment is at risk, you raise it once. Coordinating the manufacturer, the lab and the forwarder is our responsibility, not yours.
Scope
What the program covers
An FSO program is assembled from the modules below. The exact configuration is agreed before contracting so the boundary of responsibility is explicit on both sides.
Sourcing & Qualification
- Manufacturer identification and shortlisting against your specification
- Capacity, route and cost-structure assessment
- Sample coordination and analytical comparison
- On-site supplier audit, commissioned and reviewed
- Dual-source strategy where continuity risk justifies it
Quality & Documentation
- Specification alignment between your requirement and the manufacturer's method
- CoA, MSDS, impurity profile and residual solvent review
- DMF / CEP status tracking and access-letter coordination
- Change control notification and impact assessment
- Deviation and complaint handling with the manufacturing site
Supply & Delivery
- Production slotting and lead-time management
- Batch scheduling against your forecast
- Export documentation and customs classification
- Cold-chain and hazardous-goods handling where applicable
- Delivery to the agreed Incoterm with tracked milestones
Accountability
Where the boundary sits
Ambiguity about who owns what is the most common reason a supply program degrades. This is the default split for an FSO engagement; it is confirmed in writing before work starts.
| Activity | Your team | Unibest |
|---|---|---|
| Product specification | Defines the target specification and acceptance criteria | Translates it into a manufacturing and analytical brief; flags where the specification is not achievable at the intended scale |
| Manufacturer selection | Approves the final shortlist | Identifies, screens and qualifies candidates; presents a comparative assessment with a recommendation |
| Supplier audit | May join the audit and receives the full report | Commissions, attends and reviews the audit; drives corrective actions to closure |
| Regulatory documentation | Owns its own filing and interactions with the authority | Secures, reviews and maintains the supplier-side documentation the filing depends on |
| Order and forecast | Provides a rolling forecast and issues purchase orders | Slots production, manages lead time and reports schedule risk before it affects you |
| Quality events | Raises the event and defines the business impact | Investigates with the manufacturing site and returns a root cause and corrective action |
| Logistics | Confirms the destination and receiving requirements | Arranges export documentation, freight and delivery to the agreed Incoterm |
Product specification
Your team
Defines the target specification and acceptance criteria
Unibest
Translates it into a manufacturing and analytical brief; flags where the specification is not achievable at the intended scale
Manufacturer selection
Your team
Approves the final shortlist
Unibest
Identifies, screens and qualifies candidates; presents a comparative assessment with a recommendation
Supplier audit
Your team
May join the audit and receives the full report
Unibest
Commissions, attends and reviews the audit; drives corrective actions to closure
Regulatory documentation
Your team
Owns its own filing and interactions with the authority
Unibest
Secures, reviews and maintains the supplier-side documentation the filing depends on
Order and forecast
Your team
Provides a rolling forecast and issues purchase orders
Unibest
Slots production, manages lead time and reports schedule risk before it affects you
Quality events
Your team
Raises the event and defines the business impact
Unibest
Investigates with the manufacturing site and returns a root cause and corrective action
Logistics
Your team
Confirms the destination and receiving requirements
Unibest
Arranges export documentation, freight and delivery to the agreed Incoterm
Process
How a program is run
Every FSO engagement follows the same six stages. Timelines vary with molecule complexity and the regulatory status of the target market.
- 01
Requirement definition
We work through the specification, intended market, regulatory pathway, annual volume and timing. The output is a written program brief that both sides sign off — including what is out of scope.
- 02
Sourcing & assessment
Candidate manufacturers are screened on route, capacity, quality history and documentation status. You receive a comparative assessment rather than a single name, so the decision stays yours.
- 03
Qualification
Samples are produced and analysed against your specification. An on-site audit is commissioned and any findings are driven to closure before the supplier is approved for the program.
- 04
Program setup
Commercial terms, quality agreement, change-control protocol, forecast cadence and escalation path are put in place. Documentation baselines are captured so drift can be detected later.
- 05
Supply execution
Production is slotted against your forecast, batches are released against the agreed specification, and shipments move under managed export documentation to the agreed Incoterm.
- 06
Ongoing oversight
Supplier performance, documentation currency, change notifications and continuity risk are reviewed on a fixed cadence. Re-qualification and second-source activation are handled before they become urgent.
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.
| 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
Fit
When FSO is the right model
FSO is not the correct answer for every purchase. It earns its place when coordination cost is high or continuity matters more than unit price.
You are entering a regulated market
Documentation quality and supplier qualification determine whether the filing succeeds. Coordination failures are expensive at this stage.
The molecule is commercially critical
A stock-out or a quality event affects revenue directly, so continuity planning and dual sourcing justify their cost.
Your team is lean
You do not have — and do not want to build — an internal sourcing, audit and supplier-quality function for a limited number of molecules.
Previous sourcing has drifted
The supplier changed a route, a document expired, or a specification quietly diverged, and nobody owned the gap.
Questions
Frequently asked
No. A trading arrangement transfers title to material. An FSO program transfers accountability for a set of coordination activities — supplier qualification, audit closure, documentation upkeep, change control and delivery — that a trading relationship leaves with the buyer.
Describe your molecule and market
Send the specification, target market and indicative volume. You will get an assessment of feasibility and the sourcing approach we would recommend.
Related
Other ways we can be engaged
How can we help you?
Receive insights into the latest events and regulatory updates
Sent directly to your email
Get industry insights and Unibest news here
Contact Us →