The purpose of preliminary assessment is not to promise manufacture. It is to decide whether the parties should invest in confidential due diligence and, if so, what evidence and work plan are required.
Four project scenarios
Minimum non-confidential information
- requesting organization and contact
- dosage form and presentation
- target country or region
- current project stage
- CMO, CDMO, technology transfer or registration-cooperation objective
- high-level sterilization or process route where relevant
- indicative batch or demand range if non-confidential
- desired decision and timing
- known constraints that can be stated without disclosing know-how
Initial decision matrix
| Decision area | Question to answer | Possible outcome |
|---|---|---|
| Legal and license fit | Are the proposed legal entities, site scope and target-market roles compatible? | Proceed, define a licensing path, or stop. |
| Product and process fit | Can the product route, equipment, containment, sterilization, packaging and scale be responsibly assessed? | Proceed to technical diligence, request targeted evidence, or hold. |
| Quality-system fit | Can the parties connect audits, data, deviations, changes, release and lifecycle oversight? | Open quality diligence or resolve governance gaps first. |
| Transfer readiness | Is there sufficient product knowledge, method readiness, development history and accountable expertise? | Define a transfer plan, add development work, or stop. |
| Regulatory path | Who owns the dossier and which variations, inspections, filings or local responsibilities are expected? | Build a regulatory workstream or defer the project. |
| Capacity and supply | Are batch scale, campaign model, materials, forecast, timing and release route realistic? | Reserve planning assumptions, redesign supply, or decline. |
| Commercial alignment | Are scope, risk, acceptance criteria, ownership and cost assumptions sufficiently defined? | Prepare an indicative proposal or close gaps. |
Six controlled stages
Confirm the organization, objective, dosage form, market, stage and timing.
Define permitted use, access, return or destruction and authorized recipients.
Review technical, quality, regulatory, supply and commercial evidence against an agreed request list.
Define deliverables, owners, acceptance criteria, risks, cost assumptions and critical path.
Execute controlled process, method, engineering, stability and validation work as applicable.
Confirm registration, release, supply, governance and lifecycle controls before routine manufacture.
Conditions that should place a project on hold
- the legal entity, site or licensed scope cannot be confirmed
- the product route is incompatible with the facility or cannot be assessed responsibly
- critical product knowledge or accountable technical ownership is missing
- sterility, containment, co-line or data risks cannot be controlled
- the parties cannot agree quality responsibilities or access to evidence
- the proposed schedule bypasses transfer, validation or regulatory obligations
- commercial assumptions depend on unverified demand, approvals or guaranteed outcomes
- confidential information is offered before appropriate controls are in place
Response standard: A complete first inquiry is acknowledged through the website system. The current public response target is within three business days. A response may request clarification; it is not an acceptance of the project or a quotation.
Authoritative sources
This page is a public decision framework, not a project acceptance, capacity reservation, quotation or regulatory opinion.