We work across a qualified network rather than one facility, so a single certification list would not accurately describe us. Each site's approvals and standing are confirmed when a specific product and destination market are on the table.
| Format | What it is |
|---|---|
| CTD / eCTD | The ICH-harmonised five-module dossier and its electronic implementation. Mandatory for US FDA and EMA submissions. |
| ACTD | The ASEAN Common Technical Dossier — four parts, no Module 2. The format for Malaysia and across ASEAN. |
| ANDA §505(j) | US generic application demonstrating bioequivalence to a Reference Listed Drug. |
| NDA §505(b)(2) | Hybrid US application relying partly on data the applicant does not own — the route for new strengths, routes, combinations or reformulations. |
| DMF / ASMF / CEP | Confidential API filings: US Type II DMF, the EU Active Substance Master File, and the EDQM Certificate of Suitability. |
| Country registration pack | COPP, free sale certificate, GMP certificate, manufacturing licence, certificate of analysis, specifications, method validation, stability data, bioequivalence where required, local-language artwork and power of attorney. |
Zone IVb is the practical gatekeeper for ASEAN, Brazil, the Gulf and much of Africa. A dossier built on Zone II data does not travel there, and establishing that at registration stage costs a year.
Zone assignments vary between references; shown indicatively.
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.