Supply Foundation
API & Intermediate Supply
Access to manufacturing capacity is where every program starts. What determines whether it holds is qualification depth, documentation discipline and continuity planning.
Overview
Capacity is common; qualified capacity is not
Finding a manufacturer that can make a molecule is rarely the constraint. Finding one that can make it to a defensible specification, document it in a form a regulator will accept, notify changes reliably, and still be available in eighteen months is a much narrower search.
Our supply base spans small-molecule APIs, registered and advanced intermediates, excipients and custom synthesis, alongside a biological ingredient portfolio covering nucleic acids, peptides, antibodies and cell and gene therapy materials.
Every supplier that enters a program is qualified against the same standard, whether the engagement is a single purchase or a multi-year FSO program.
Specification-first sourcing
Candidates are screened against your analytical requirement and intended market, not against a catalogue listing.
Route and impurity transparency
Synthetic route, starting material and impurity profile are reviewed up front, because these are what constrain your filing later.
Documentation as a deliverable
CoA format, DMF status, stability data and change-notification terms are agreed before the first order, not chased afterwards.
Continuity built in
Where a molecule is commercially critical, a second source is identified and kept warm rather than discovered during a shortage.
Scope
Portfolio coverage
The searchable product libraries hold the current listed portfolio. Anything not listed can be sourced or synthesised to specification.
Small Molecule
- Active pharmaceutical ingredients
- Registered and advanced intermediates
- Pharmaceutical excipients
- Custom synthesis to client specification
- Specialist chemistry including chiral, fluorination, coupling and hydrogenation routes
Biologics & Advanced Modalities
- Nucleic acids and oligonucleotides
- Peptides
- Antibodies and antibody fragments
- Cell and gene therapy raw materials
- PROTAC and conjugation building blocks
Supporting Services
- Analytical comparison and sample coordination
- Supplier audit and requalification
- Documentation and change-control management
- Export documentation and cross-border delivery
- Second-source identification and activation
Process
From enquiry to first delivery
A standalone supply enquiry follows a shorter path than a full program, but the qualification standard does not change.
- 01
Enquiry & specification
You provide the molecule, the specification, the intended market and an indicative volume. We confirm whether it sits in the current portfolio or requires a sourcing exercise.
- 02
Feasibility & indication
Route, capacity and documentation status are checked, and you receive an indicative price and lead time with the assumptions behind them stated.
- 03
Sample & analysis
Samples are produced or drawn from an existing batch and analysed against your specification. Any deviation is discussed before commercial terms are agreed.
- 04
Qualification
For commercial supply, the manufacturing site is audited and the documentation package is assembled and reviewed before approval.
- 05
Commercial supply
Production is slotted against your forecast and shipments move under managed export documentation to the agreed Incoterm.
Questions
Frequently asked
Yes. Standalone purchases are supported. The qualification standard applied to the manufacturer is the same; what differs is the ongoing oversight, continuity planning and documentation upkeep that a program adds.
Send us a specification
Share the molecule, specification and target market and you will get a feasibility view with indicative lead time.
Related
Other ways we can be engaged
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