​​ In cutting-edge fields like stem cells, organoids, exosomes, and gene therapy, every step of scientific research holds the potential for groundbreaking discoveries. Yet, many teams repeatedly stumble at the same hurdle:
 

Want to get tested, but No equipment, no manpower, no qualifications ——Absolutely can't do it.

Although the lab can generate data, The method is unverified, and the system fails to meet standards. ——The results are not recognized.
 

Thus, even though the data is accurate and the experiments are rigorous, they lack a robust management system and fail to gain endorsement from authoritative institutions. Paper rejections, stalled IND submissions, and skepticism from collaborators—these may well be the most frustrating bottlenecks in translating research into real-world applications.

Meanwhile, a test report bearing the CNAS accreditation mark often serves as the "golden ticket" that opens the door to authoritative recognition.

Jiuzhitang MakerCQDMO Product Testing Platform

Jiuzhitang MakerCQDMO's product testing platform, powered by CNAS-accredited laboratory (Registration No.: CNAS L20479) The quality system, built in line with the principles of the Pharmaceutical Quality Management System (GMP), has provided testing services compliant with the requirements of both Volume 3 of the Chinese Pharmacopoeia and ICH Q5–Q6 to institutions including the Chinese Academy of Sciences network, top-tier Grade III hospital research centers, innovative drug development companies, and CRO organizations. This support helps transform research data from "internal results" into compliant evidence that is "submitable, citable, and auditable."

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Main detection services and targets

Jiuzhitang MakerCQDMO platform deeply understands: The same cell sample requires entirely different detection targets and reporting requirements at various stages of development. To this end, we offer Testing services tailored to different R&D stages ：

Research exploration phase: Requires "recognized data"

Applicable to: Higher education institutions, hospital research teams, and emerging biotechnology companies

Typical requirement: Validate cell identity, assess functional activity, and eliminate microbial contamination—supporting mechanistic studies or animal experiments.

We offer:

Standardized Testing Items (30+) , covering dimensions such as cell identification, safety, and activity;

The analytical method is established based on the Chinese Pharmacopoeia and industry consensus, with method validation completed (e.g., specificity, accuracy, precision, etc.).

The report includes the detection method, measured results, original spectra (optional), and CNAS Accreditation Mark (Applicable Projects) ；

The format meets the requirements of mainstream journals for "third-party verified data," helping ensure a smooth publication process.
 

Elevate your research data—from "internal findings" to "externally credible evidence."

Registration and submission phase: "Submitable data" required

Applicable to: Pharmaceutical companies, contract research organizations, and biotechnology firms

Typical requirement: Obtain compliant testing data that meets the requirements of the National Medical Products Administration (NMPA) and can be incorporated into drug registration submissions.
 

We offer:

CNAS-accredited testing services, The report bears the official CNAS accreditation mark and is recognized as a reliable basis for judicial acceptance, with internationally accepted validity.

All methods completed Complete methodological validation (According to ICH Q2(R1) and the Chinese Pharmacopoeia), covering critical parameters such as accuracy, precision, linearity, limit of detection, and limit of quantitation;

Ready-to-Use Testing Services :The critical control points of the testing process are carried out in accordance with the relevant principles of the Pharmaceutical Production Quality Management Guidelines (GMP), utilizing an electronic laboratory information management system to ensure data integrity (ALCOA+ principles) and enabling efficient responses to regulatory inspection requirements.
 

We deliver not just a report, but also compliant evidence ready for submission to regulatory authorities.
 

Jiuzhitang Maker Demonstrates Testing Capabilities
 

As a CNAS-accredited third-party testing laboratory, Jiuzhitang Maker’s Quality Control Department leverages pharmaceutical-grade quality principles and internationally recognized testing capabilities to establish a comprehensive testing system that covers the critical quality attributes of cell therapy products. Our technical expertise is reflected in the following six key areas:

Official Certification:

The test results have credibility and a compliant foundation.

CNAS Laboratory Accreditation: It has been officially accredited (Registration No.: CNAS L20479) by the China National Accreditation Service for Conformity Assessment (CNAS), with testing capabilities compliant with the international standard ISO/IEC 17025:2017. As a result, its test results are authoritative, impartial, and enjoy full international recognition.

GMP Compliance System: The laboratory's quality management system is built in alignment with the core requirements of the Pharmaceutical Manufacturing Quality Management Practices (GMP), providing a robust, data-compliant foundation for future Investigational New Drug (IND) applications.
 

Comprehensive multi-dimensional detection capability:

The Five Key Dimensions of Cell Product Coverage

Under the requirements of a robust quality control system, We offer More than 30 items Standardized testing procedures, including those for cell-based products Identification, activity, safety, functionality, and genetic stability , primarily covering:

All tests were conducted in accordance with Chinese Pharmacopoeia Volume III, ICH Q5–Q6, and relevant international guidelines. The methods have been validated, and the data are fully traceable throughout the process.
 

Scientific detection method:

Hardware, team, and processes—a three-pronged approach

All detection methods have undergone methodological validation or verification, with key parameters including sensitivity, specificity, precision, linear range, and accuracy.

Full-process execution of standardized operating procedures SOP ), key steps are electronically recorded to ensure data traceability and auditability, while also supporting third-party reviews.
 

Professional Support System:

Hardware, team, and processes—a三位一体 approach

Advanced Equipment Cluster:

Equipped with a flow cytometer, Real-time Fluorescent Quantitative PCR System , fully automated microbial detection platforms, high-resolution imaging systems, and more;

Comprehensive Quality Control Team:

Composed of master's and doctoral graduates with backgrounds in cell biology, molecular diagnostics, and pharmaceutical quality control, they possess hands-on experience in GMP-compliant laboratories.

Strictly managed zoning:

Cell detection area, molecular detection area, microbiology area, and physicochemical area are physically segregated to prevent cross-contamination.

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Transparent Delivery:

Each batch comes with a "scientific ID card."

Each commission includes a structured "Cell Quality Report," which contains:

Testing items, methods, and reference standards

Measured results, assessment conclusions (optional), original spectra (optional)

CNAS accreditation mark (certification program), issuer information

The report format complies with the requirements of academic journals and regulatory agencies, while also enabling historical batch data comparisons to ensure research continuity and consistency across batches.
 

Aligned with clinical submissions:

Standard verified by real-world scenarios
 

The requirements for assay setup, acceptance criteria, and method validation are all aligned with the quality control system used in Phase I/II clinical trials of registered stem-cell-based new drugs.

The relevant testing data have been successfully used in clinical trial applications for three stem cell products and have passed the technical review by the Center for Drug Evaluation (CDE) under the National Medical Products Administration, with no supplementary requests issued due to testing-related issues.
 

Jiuzhitang Maker, built on the foundation of CNAS accreditation,

Guided by pharmaceutical-grade standards,

Ensure that every test report can withstand scientific replication and regulatory scrutiny.