Capabilities · where the early questions live

Complex APIs, by class.

We work where the early go/no-go questions are hardest — the classes where answering them years before launch decides whether a generic programme succeeds. Not a catalogue: the questions that decide the programme, and the answers that come first.

High-potency APIs

Cytotoxic and highly potent chemistry, handled to containment

Potent chemistry is where a route can look simple and behave badly at scale. We answer the containment, cost and filing questions before a programme commits.

FeasibilityIs the route viable at commercial scale, with containment?
Cost at scaleWhat does a kilo cost at launch — with the working shown?
HandlingWhat containment and industrial-hygiene overhead does the process carry?
Filing pathWhat stands between us and a filing, by region?

Oligonucleotides

Nucleosides and oligonucleotide APIs for a growing generic field

Sequence chemistry rewards early process thinking. The questions that decide an oligonucleotide programme are synthesis, control and the filing route.

SynthesisDoes the sequence synthesise and purify at scale?
AnalyticsCan impurities be controlled to specification?
Filing pathWhat does the regulatory path look like, by region?
SupplyWhere does the raw-material supply concentrate?

Anti-viral APIs

For long-acting and oral anti-viral programmes

Anti-viral programmes turn on route, presentation and the timing of entry. We answer those before the development budget is committed.

RouteIs the route feasible for the scale and presentation required?
PresentationWhat changes for long-acting versus oral formats?
Filing pathWhat is the filing route and timeline, by region?
Supply riskWhat are the supply and route risks?

Biologicals

Enzyme and hormone APIs, with technology-transfer support

For biologicals the question is transferability: whether the process scales reproducibly and can be controlled to specification. That is answered early or not at all.

TransferCan the process transfer and scale reproducibly?
CharacterisationHow is the product characterised and controlled?
Filing pathWhat does the filing path require, by region?
SourcingWhat are the sourcing and cold-chain risks?

Also: biosimilars — programme and registration support for follow-on biologics.

Not a catalogue

Tell us the API and the stage.

If we can answer, we will. If we can't, we'll say so — and tell you what would change that.

Ask the question See the Decision Support tool