Manufacturing & Supply
Most brands select a contract manufacturer on price, capacity and a plausible conversation. The problems surface later, at pilot, at stability, or at the point where a regulator asks a question the manufacturer cannot answer. By then the tooling is cut, the batch record is written and the cost of moving is severe.
Qualification is the work of establishing, in advance and in writing, that a manufacturer can actually make your product to the standard your market requires.
Capability gaps
A typical manufacturer brief describes the product. It rarely describes the capability required to make it. That distinction matters most where the product sits just outside a manufacturer’s normal range: a low-dose active in a large unit, an unusual dosage form, a market whose GMP scope the site does not hold.
01
Dose uniformity at low inclusion
A 50 microgram active in a one gram tablet has to be uniform in every unit, not just on average across the batch. Sites that run high-inclusion powders routinely have the equipment but not the blending validation or the analytical sensitivity to prove it.
02
Dosage forms outside the normal range
Softgels, chewables, effervescents, sachets and gummies each carry their own tooling, moisture control and stability behaviour. A site that quotes on one because it owns a filler is quoting on capacity, not capability.
03
GMP scope that does not cover your market
A site licensed for food or dietary supplements is not licensed for therapeutic goods. Scope is specific to the licence, the dosage form and the jurisdiction, and it is checked at registration, not at quotation.
04
Analytical capability for your actives
A manufacturer that cannot assay your active in the finished matrix cannot release against your specification. Outsourced testing is acceptable, but it has to exist and the method has to be validated for your product, not for the raw material.
The consequence
A food or supplement site asked to quote on a product outside its licensed scope will quote. The disqualifying detail is not usually withheld deliberately; it simply never comes up, because nothing in the brief required it to.
Written capability gates make candidates screen themselves out before you spend a cycle evaluating them.
The method
We define the requirements that are mandatory rather than scored. A manufacturer either evidences these or is out.
GMP scope and market clearance
Handling and containment for the active
Dose uniformity controls
Analytical capability
Tooling for the intended format
A validated route from pilot to commercial under one quality system
We write the disqualifying criteria into the brief, so candidates screen themselves.
Development performed by a separate party with no controlled transfer
Terms that retain ownership of improvements to your formula
No capability to run or govern the release testing your product needs
Commercial terms, minimum order quantities, cost ladders, lead times and capacity are scored, not gated. That keeps price in its proper place: a tiebreaker between manufacturers who can already do the job.
Candidates respond against the matrix with licences, certificates, inspection history and process data. Yes-or-no answers are not accepted.
Deliverables
A manufacturer brief issued under NDA, a scored comparison matrix, and a structured first feasibility request. Unit cost is built from real quotes rather than estimated in advance.
Supplier qualification
Formulation work
Analytical method development
Stability
Tooling
Packaging
Commercial batch costs
Each line individually quoted
Whether you are writing a first brief, comparing shortlisted sites, or discovering mid-programme that a manufacturer cannot hold the scope your market requires, the starting point is an honest read of what the product actually needs.