Quality & Registration
We sell products that can be registered. That means documentation prepared properly, in the format your authority asks for.
DOCUMENT PACKAGE
What you receive with each project.
Certificate of Pharmaceutical ProductCoPP attesting registration status in China, issued in the WHO-recommended format.
Certificate of AnalysisBatch-specific CoA against registered specification, released by the QA unit.
Certificate of Free SaleFSC documentation confirming the product is marketed in the country of manufacture.
GMP CertificateCertificate evidencing compliance with current Chinese GMP requirements for the relevant dosage form.
Open / Closed DMF PartActive substance documentation supplied where the importing authority requires it.
Stability DataReal-time and accelerated data per ICH climatic zones, maintained continuously.
Batch Manufacturing RecordsTraceable batch documentation available for audit and regulatory inspection.
Spanish TranslationProduct information and documents translated into Spanish for Latin American submissions.
REGISTRATION SUPPORT
How we support your submission.
01
Product shortlist
Send the molecules and strengths you need. We confirm availability, registration status in your market and minimum order quantity.
02
Quotation & samples
Commercial offer within 48 hours, with reference samples and specifications shipped for evaluation.
03
Dossier transfer
CTD or ACTD set prepared in English, translated into Spanish where required, handed to your regulatory team.
04
Production & release
Order manufactured under GMP, batch tested, released with CoA and delivered with full export documentation.
The paperwork is part
MODULE 1–5CTD DossiersCompiled to ICH CTD structure — administrative, quality, non-clinical and clinical modules ready for submission.
ASEAN FORMATACTD DossiersFull Part I–IV ACTD sets prepared for ASEAN and national authorities that follow the ASEAN Common Technical Dossier.
BATCH RELEASECoPP & CoACertificate of Pharmaceutical Product and batch-specific Certificate of Analysis issued with every shipment.
FREE SALEFSC SupportCertificate of Free Sale documentation coordinated alongside the dossier for your registration file.
STABILITYOngoing DataReal-time and accelerated stability data maintained per ICH climatic zone requirements for your market.
DMF / OPEN PARTAPI Source FilesOpen and closed parts of the active substance master file provided where the authority requires it.
Tell us which molecules you need.
We will come back with availability and price.
Send the product list, strengths and target market. You will get a commercial offer within 48 hours — including the registration documents we can support for your country.