OEM/ODM/CDMO
Our R&D team has extensive experience in product design, development, production, regulations, listing and has a professional market evaluation and sales team to achieve customer satisfaction. A plant that complies with Taiwan’s QMS (GMP) / ISO 13485 equipment and has passed the GMP production qualifications in China and South Korea, capable of manufacturing in vitro diagnostic reagent products that meet global clinical requirements. We successfully possess a lot of international partnerships, and you could verify your products in your target market through our global partnerships.
Quality authentication
Pharmigene’s Taipei factory complies with ISO 13485 medical devices Quality Management Systems (QMS) standards. It will regularly review and optimize the factory management process and ensure that the medical equipment products or services produced have consistent quality standards. In addition, it has obtained China/Taiwan/Korea Good Manufacturing Practice GMP quality certification, and the products will be designed and manufactured following international standards and established specifications to achieve quality consistency.
| Certification | |
|---|---|
| 2020 | The certification of Taiwan Food and Drug Administration (TFDA) LDTs is under processing. |
| 2018 | Passed the TFDA pilot LDTs counseling check.Taipei factory passed the ISO13485: 2016 transfer certification (Certification agency: Bsi) |
| 2016 | Pharmigene obtained Korea GMP certification. |
| 2015 | Pharmigene's HLA-B*1502、HLA-B*5801 Detection Kit got CFDA approval. |
| 2012 | New manufacturing plant was built, and the headquarter relocated to new office in Taipei (Neihu). Taipei Plant acquired good manufacturing practice (GMP) certification. |
| 2009 | The Xizhi factory obtained the Good Manufacturing Practice (GMP) certificate from the Department of Health of the Executive Yuan of the Republic of China. |
| 2008 | Ministry of Economic Affairs factory registration certificate (Xizhi Factory: Dahu Science-Based Industrial Park) |
| 2006 | Pharmigene obtained ISO 13485. |
| 2005 | Founded Pharmigene, Inc |
The Precision Medical Integrated Factory of PharmiGENE
QMS(GMP)/ISOmedical apparatus and instruments factory
ISO 13485, TFDA, CFDA, CE-IVD, Singapore HSA, KFDA, US FDA ASR
LDTs Measurement Laboratory
LDTs Laboratory Accreditation is under processing.
The technological capabilities of PharmiGENE
Technology
Real-time PCR
Enzyme-linked immunosorbent assay, ELISA
OEM/ODM
Research Use Only (RUO)
CE mark
In Vitro Diagnostic Device, (IVD)，「B.4020 (Analyte specific reagents, ASR) 」
OEM Applications
Infectious diseases detection
Cancer detection panel
Cancer prognosis detection
Cell therapy
Cancer Drug Evaluation
