OEM Saurin Gwajin Sabis - ODM & Ƙirƙirar Label mai zaman kansa

Ayyukan Gyaran Mu

Ƙirƙirar Fasaha mai zurfi a kowane mataki

Ba kawai mu sanya tambarin ku a cikin akwati ba - muna isar da ingantattun injiniyan samfur don tabbatar da gwajin magungunan OEM ɗinku ya cika takamaiman ƙa'idodin kasuwa, ƙa'idodin asibiti, da ƙarshen - tsammanin mai amfani.

Custom Assay & Multi - Panels Drug

Tsara ainihin kwamitin da kasuwar ku ke buƙata - haɗa ƙididdiga masu yawa a cikin na'ura ɗaya, wanda aka daidaita zuwa yanayin cin zarafi na yanki da yanke ka'idoji na gida.

Har zuwa sigogin magunguna 18 a cikin na'ura ɗaya
Yanke matakan al'ada (SAMHSA, EMCDDA, AS/NZS, bespoke)
Fitsari, miyau (ruwa na baka), da matrices gashi

Nemi Magana →

Tsarin Na'ura & Tsarin Jiki

Bambance tambarin ku tare da nau'ikan nau'ikan jiki na musamman. Muna ba da gyare-gyaren gidaje da yawa kuma za mu iya canza yanayin tsari da tsarin launi don dacewa da zaɓin kasuwanku.

Strip, Cassette, Dip-Kati, ko Tsarin Gasar Cin Kofin Haɗe-haɗe
Launukan gidaje na al'ada da zane-zanen lakabi
Tamper- hatimi bayyananne da zina - duba haɗin kai

Nemi Magana →

Marubucin Lakabi mai zaman kansa

Isar da haɗe-haɗe gwanin alama daga katako na waje zuwa jakar gwaji ɗaya. Ƙungiyoyin ƙira na cikin gida suna samar da ƙwararru, ƙa'ida - aikin zane mai dacewa don amincewar ku.

Na al'ada - bugu nitrogen - jakunkuna na foil
Multi - Harshe IFU (Usoro don Amfani) abubuwan sakawa
Katunan sayar da kayayyaki masu alama da babban asibiti - akwatunan kaya

Nemi Magana →

Tallafin Taimako na Ka'idoji

Kewaya ƙa'idodin na'urar likita yana da rikitarwa. Muna ba da cikakkun takaddun fasaha da jagorar ƙwararrun da ake buƙata don yin rajistar samfuran ku na sirri - alamar IVD a duk duniya.

Litattafan fasaha don CE IVDR, FDA, TGA, da ANVISA
Ayyukan nazari & bayanan binciken asibiti akan fayil
Takaddun Takaddun Siyarwa na Kyauta (FSC) da takaddun iyakokin ISO 13485

Nemi Magana →

OEM Product Catalog

Cikakken Fayil ɗin Gwajin Saurin IVD Akwai don OEM

Kewayon OEM ɗinmu ya mamaye mafi girman - nau'ikan buƙatu a cikin duniya - na- bincikar kulawa, duk an ƙera su ƙarƙashin GMP ɗaya- ƙwararrun tsarin inganci.

Magungunan Zagi - Gwajin fitsari

Single-tallafi guda zuwa 18-haɗe-haɗen kofuna don wuraren aiki, na asibiti, da shirye-shiryen tantancewa.

THCCOCAMP/MAMPOPI/BUPBZO/MDMAFYL/K2

Tambaya Yanzu →

Magungunan Zagi - Ruwan Baki

Gwaje-gwajen ruwa na bakin hanya marasa cin zarafi da wurin aiki, gami da DRUID- na'urorin da suka dace don amfani da doka.

THCCOCAMP/MAMPOPIMulti-Panel

Tambaya Yanzu →

Magungunan Zagi - Gwajin Gashi

Na'urorin binciken gashin kai na gefe suna samar da taga gano kwana 90 don shari'a, inshora, da tantance aikin.

90-Tarihin RanaMulti-PanelFarashin ELISA

Tambaya Yanzu →

Gwaje-gwaje masu saurin kamuwa da cuta

CE - Alamar antigen da gwajin sauri na antibody don alamun cututtukan cututtuka masu mahimmanci a cikin saitunan asibiti da na al'umma.

HIV 1/2HBsAgmura A/BCOVID-19 AgZazzabin cizon sauro

Tambaya Yanzu →

Gwajin ciki & Haihuwa

Babban - Gwajin hCG, LH, da FSH don mabukaci da kasuwanni na asibiti tare da faffadan zabukan tambarin masu zaman kansu.

hCG tsirihCG kasetLH OvulationFSH Menopause

Tambaya Yanzu →

Alamar Zuciya & Tumor

Point-of- Gwaje-gwaje masu sauri na kulawa da ƙididdigewa don gaggawar gaggawa na zuciya da gwajin ƙwayar cuta da wuri.

Troponin IBNPD-DimerPSAAFP

Tambaya Yanzu →

Yadda Muke Aiki

Tsari na Masana'antar OEM Label mai zaman kansa

An inganta shi sama da shekaru 15 don ɗaukar samfurin ku daga ra'ayi zuwa ƙaddamar da kasuwanci cikin sauri da amintaccen mai yiwuwa.

Shawarwari na farko & Sa hannun NDA

Muna aiwatar da NDA na juna kafin a raba kowane bayanan mallakar mallaka. Tsarin binciken da aka tsara sannan ya ƙunshi kasuwa da aka yi niyya, sassan magunguna, yanke - ƙa'idodi, zaɓin tsari, da ƙididdige adadin shekara-shekara.
⏱ 1-3 Ranakun Kasuwanci
Samfuran Samfura & Tabbatar da Aiki

Ƙungiyar R&D ɗinmu tana ƙirƙira kuma tana tattara samfuran samfuri na aiki gwargwadon ƙayyadaddun ku. Ana aikawa da samfurori zuwa gare ku don a-Kimanin dakin gwaje-gwaje na gida, ingantacciyar aikin asibiti, da ƙa'ida kafin kimantawa.
⏱ Kwanaki 7-21 Kasuwanci
Ƙarshen Zane-zane & Takardun Tsarin Mulki

Da zarar an amince da samfurori, ƙungiyar ƙirar mu za ta kammala duk ayyukan fasaha na marufi masu zaman kansu. A lokaci guda, ƙungiyar mu mai kula da al'amuranmu tana tattara Dossier Fasaha don rajistar ƙaramar hukuma.
⏱ Kwanaki 10-15 Kasuwanci
OEM Kwangilar Kisa & GMP Mass Production

Tare da aikin zane-zane da takaddun tsari da aka amince da su, mun sanya hannu kan yarjejeniyar samar da OEM. Odar ku yana shiga samarwa a cikin GMP-Shararrun ɗakuna masu tsafta tare da layukan taro masu sarrafa kansa don saurin aiki, daidaiton kayan aiki.
⏱ Kwanakin Kalanda 30-45
Cikakkun Sakin QC & Dabaru na Ƙasashen Duniya

Kowane kuri'a yana jurewa cikakken baturin QC - giciye - bangarorin amsawa, hankali/takamaimai, saurin kwanciyar hankali, bayyanar - kafin a ba da Takaddun Bincike. Sannan muna daidaita jigilar kaya zuwa ma'ajiyar ku.
⏱ 5-7 Kwanaki QC + jigilar kaya

Ƙarfafa Ƙarfafawa

GMP - ƙwararrun masana'antun kayan gwajin sauri

ISO Class 8 (100,000) GMP Tsabtace

Duk lamination membrane, conjugate pad shirye-shirye, da na karshe tsiri taron faruwa a cikin tabbataccen matsa lamba, barbashi - Kulawa da ISO Class 8 dakunan tsabta - injiniya don kawar da gurɓata kowane mataki.

Zazzaɓi mai ƙarfi (RH ≤ 20%) da sarrafa zafin jiki suna ba da garantin kwanciyar hankali na ƙwayoyin cuta na antibody - antigen conjugates, yana tabbatar da ingantacciyar rayuwar 24-watanni a duk layin samfuran OEM.

ISO 8Ajin Tsaftace

RH ≤20%Kula da ɗanshi

24 Mo.Rayuwar Rayuwa

Babban - Layukan Samar da Maɗaukaki Na atomatik

CNC - Injinan sliting sarrafawa, robotic - Tashoshin taro masu taimako, da nitrogen mai sarrafa kansa - jakar ruwa - Layukan rufewa suna biyan buƙatun girma na duniya yayin da rage girman ɗan adam

Ƙarfin samar da mu ya wuce gwaje-gwajen da aka gama 100,000 a kowace rana, yana ba da damar lokutan samar da taro na OEM na kwanaki 30 zuwa 45 daga sa hannun kwangila.

100K+Gwaji / Rana

30-45Lokacin Jagorancin Rana

<5% CVLutu Daidaituwa

Dogara Dogara

Takaddun shaida na Ƙasashen Duniya

Kayan aikinmu da samfuranmu sun cika ƙaƙƙarfan ƙa'idodin IVD na duniya, suna ba samfuran OEM ɗin ku sanannen tushe na inganci na duniya.

Duba Takaddun shaida

Labaran Nasara Abokin Hulɗa

Amintacce ta Samfuran IVD A Gaba ɗaya Nahiyoyi Shida

Dogon haɗin gwiwar OEM na dogon lokaci tare da samfuran kiwon lafiya, masu rarrabawa, da hukumomin sayan gwamnati a duk duniya.

Juyawar samfurin su ya yi sauri fiye da kowane masana'anta da muka kimanta. Al'ada 10 - kofin fitsari da muka haɓaka - haɓaka yanzu shine babban mu - siyar da SKU a cikin kasuwar lafiyar ma'aikata ta Turai.

David L.Daraktan Kasuwanci - Mai Rarraba IVD, Jamus 🇩🇪

Muna buƙatar FDA-takardun da suka dace don duk masu zaman kansu - layin gwajin muggan ƙwayoyi a cikin ɗan gajeren lokaci. Tawagar su masu kula da su sun isar da cikakkun bayanai kuma sun goyi bayan tsarin rajistar mu.

Sarah R.VP na Kayayyaki - Alamar Kiwon Lafiya, Amurka 🇺🇸

Bayan shekaru uku na haɗin gwiwa, daidaiton samar da su da kuma amsa suna zama abin koyi. Muna gudanar da raka'a sama da miliyan biyu a kowace shekara ta wurin aikinsu tare da fa'idodin tserewa masu inganci a rikodi.

Mohammed K.Shugaba - Kamfanin Diagnostics, UAE 🇦🇪

Tambayoyi gama gari

FAQs Abokin Hulɗar OEM

Duk abin da kuke buƙatar sani kafin fara aikinku na farko tare da mu.

Menene MOQ don gwajin magunguna na OEM?

5,000 inji mai kwakwalwa/SKU don kaset da tsarin tsiri; 2,000 inji mai kwakwalwa don hadaddun kofuna. Samfuran kimantawa (raka'a 50-200) ana samun su gaba da umarni na kasuwanci.

Har yaushe ake ɗaukar samfurin OEM?

Daidaitaccen daidaitawa: 7-10 kwanakin kasuwanci. Ƙididdigar ƙididdiga masu buƙatar sabon ci gaban nazari ko yanke al'ada - kashe titration: makonni 3-6.

Za ku iya tallafawa rajistar samfur a cikin ƙasarmu?

Ee - Cikakkun Dossiers na Fasaha don CE IVDR, FDA, TGA, da ANVISA, da takaddun shaida na ISO 13485, Sanarwa na Daidaituwa, da Takaddun Takaddun Siyarwa Kyauta (FSC).

Kuna sanya hannu kan NDA kafin tattaunawar fasaha?

Lallai. Ana aiwatar da NDA na Mutual kafin a yi musayar kowane bayanin mallakar mallaka. Akwai cikin Ingilishi, Sinanci, Sifen, da Jamusanci.

Menene daidaitaccen lokacin jagoran samar da taro?

30-45 kwanakin kalanda bayan alamar zane - kashewa da aiwatar da kwangila. Zaɓuɓɓuka masu hanzari akwai - tattauna tsarin lokacinku tare da ƙungiyar tallace-tallacenmu.

Zan iya ƙididdige matakan yankewa na al'ada?

Ee. Mun tsara zuwa SAMHSA, EMCDDA, AS/NZS 4308, UK WDTG, ko kowane abokin ciniki-yanke yanke-kashe. Duk an inganta su akan ingantattun abubuwan tunani kafin samarwa.

Kuna bayar da cikakken marufi na masu zaman kansu?

Ee - alamar ku akan mahallin na'urar, jakar foil, kwali na waje, da IFU. Babu sunan masana'anta akan samfuran ku. Fayilolin zane masu iya daidaitawa da aka bayar akan kammala aikin.

A Fara Yau