Three ways to work with us.
Programmes are costed by stage, not by hour. Each model has a defined scope, a defined deliverable and a reserved slice of capacity.
Pick the stage you need.
Process Development
Cell line, upstream and downstream development with a full analytical package. Deliverable: a locked, transferable process. Typically 9 to 12 months.
Clinical Supply
GMP manufacture for trial material, with batch records and stability. Deliverable: released clinical batches and the documentation behind them. Typically 12 to 18 months.
Commercial Supply
Validated commercial manufacture with reserved annual capacity and lifecycle support. Deliverable: continuous supply under a multi-year agreement.
What you always get.
One quality system
The same release specifications and data integrity standards across every stage.
Audit-ready records
Batch documentation and an immutable audit trail, available to your quality team throughout.
A named programme owner
One accountable person from assessment to supply, not a handover at each stage.
Before you ask.
How is a programme priced?
By stage and by reserved capacity, agreed up front against a defined deliverable. There is no hourly billing, because the risk you are buying down is schedule risk, not effort.
Can we start at clinical supply without doing development with you?
Yes. Incoming processes go through a tech-transfer assessment first, which tells both sides what the gaps are before anything is committed.
What does reserved capacity actually mean?
A fixed share of each production campaign is allocated to your programme before commercial orders are accepted. It is written into the agreement, not held informally.
Who owns the process and the data?
You do. Your process, your analytical methods and your batch data remain yours, and transfer out with you if the relationship ends.
Which markets can you file in?
The quality system is built to a single standard, so a dossier prepared for one major market needs adaptation rather than rework for the others.
Get a costed route.
Bring a target product profile and a market. We will come back with stages, timing and price.