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CDMO Services

feasibility test（2-3 M）RPAPhase Development and Validation（3-6M）PrototypeRPAIUOKitIUOPhase development and validation(6-12M）1.Project initiation2.Design Planning3.Preliminaryscreening of rawmaterials4.Selection ofTesting Platform5.Preliminaryconstruction andoptimization ofreaction system1.Design input anddesign development2.Raw material research3.Research on ReactionSystem and ProductionProcess4.Three batches of small-scale trial production5.Preliminary analysisperformanceverification6.Establishment ofpositive thresholdjudgment value1.Design output2.3 batches of GMPcommissioned production3.Registration and inspection ofreagent kit4.According to the guidingprinciples of the in vitrodiagnostic reagent industry,perform analytical performancevalidation, including sensitivity,precision, interference testing,cross reactivity, hook effect, etc5.Stability study: Long termtransportation stability, bottleopening freeze-thaw stability,sample stability6.Verification of positivethreshold judgment valueClinical trials on theaccuracy of reagent kits:preparation in advanceClinical trial trainingClinical trial kickoffmeetingClinical Trial Pre TrialFormal clinical trialsClinical trials(6-18M)1.Writing and reviewingregistration materials2.Registration acceptance3.System assessment4.Registration approval5.additional information6.precensor7.Pre audit supplement8.Review ofsupplementary materials9.Administrative approvaland certificationRegistration declaration(12-24M)IVDKitNMPAApprovedIUOKitCommissioned Development and Commissioned Production PlansCommissioned Production Management System - Platform&System CertificationEstablished product development and quality inspection laboratories covering the entire platform•R&D: The laboratory is capable of conducting research and development on PCR, NGS, and protein products.•Quality inspection: independent PCR and protein product quality inspection laboratories, microbial limit andpositive room cleanrooms of 10000 levels.High quality assurance for product development and productionThe laboratory/production workshop has obtained the EU ISO 13485 certification, passed multiple quality systemassessments by NMPA and pharmaceutical clients, and has undergone third-party simulated FDA factory audits.Establish a production workshop covering the entire platform of product production in accordance with GMPand ISO13485 requirements•There are 4 clean areas in the production workshop, including 2 production lines:1: Production of nucleic acid products (PCR products, NGS products, etc.);2：Production of protein and immune products (immunohistochemistry products, chemiluminescence products,Elisa, etc.).•It can meet the production requirements for various types of IVD products, including Type I, Type II, and Type IIIWe have established a 4 ℃ refrigerated warehouse and a -20 ℃ frozen warehouse to meet the storagerequirements for IVD and medical device products.

If you have any of the following needs, feel free to contact us or email us at inquiry@MEDxTMC.net . We will reply within 24 hours.


1. Customized or bulk orders of IVD/CDx products.

2. Get a quote for IVD/CDx products

3. Become our distributor

4. Get customized pharmaceutical service solutions

5.Learn more about our technology and R&D


Tel: +86 19984835901

Mail:inquiry@medxtmc.net

Add:Room 901,B5,Bio-Nano Park,No.218 Xinghu Street,Suzhou City,China

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