Whichever route applies, the first conversation is the same: what is the molecule, what is the market, and what does registration there actually require.
You hold the market and the registration route; we supply the product and the dossier support behind it. Suited to partners adding depth across a therapeutic area rather than listing single products.
What we need: target markets, therapeutic priorities, registration status and expected volumes.
You hold the brand and the market; we develop, manufacture and document the product, from formulation and dossier preparation through to commercial supply.
What we need: the molecule, target dosage form, market and regulatory standard required.
Selective out-licensing of proprietary assets to partners with the regulatory and commercial reach to commercialise them. Discussions proceed under confidentiality agreement before asset-specific detail is shared.
What we need: therapeutic focus, territories held and the stage at which you typically in-license.
Requesting the appropriate level shortens the process considerably. This is what each contains and what is required to release it.
| Level | Released | What it contains |
|---|---|---|
| Capability statement | On request | Company profile, divisions, dosage-form and technology coverage, therapeutic segments, market footprint, quality frameworks and contact routes. |
| Product portfolio | On request | Product list by therapeutic segment with molecule, strength, dosage form and pack presentation, filtered to your market. |
| Product dossier | Under CDA — request via quality@anzalp.com | Quality data in CTD or ACTD format, certificate of analysis, stability data by climatic zone, analytical method validation, Site Master File, GMP certificate and COPP. Released against a signed confidentiality agreement and a defined market. |
The site's approval must exist before a product file is opened. Reversing this order costs a full cycle.
CTD for regulated markets, ACTD for ASEAN via QUEST3+. Determined by the destination rather than by convenience.
Zone IVb long-term data where the market requires it, generated on the batches that will be registered.
Where required — and for endogenous hormones, with baseline correction designed in from the outset.
COPP, free sale certificate, GMP certificate, certificate of analysis, method validation and local-language artwork.
If a molecule requires a facility standard we cannot reach, a registration route that does not work in your market, or a timeline the chemistry will not support, we will say so in the first conversation.
Distribution, contract manufacturing and licensing all reach the same desk. Write to us with the product and the territory, and the first reply will be substantive.