Compliance Validation Layer · Core Hub

GLP Compliance Validation
The Platform's Core Hub

Not a "drug safety-testing lab" — compliance validation infrastructure. GLP is the only node that connects both drug compliance (ICH) and device compliance (ISO 10993), making it the hub for the entire chain.

Experience supporting NMPA filings GLP studies run within our own system, not outsourced Coverage of ICH toxicology standards

GLP safety evaluation is carried out at the Yangtze River Delta National Innovation Centre for Drug Safety Evaluation Technology. The platform operates within that national innovation system rather than as an outside client of it, and handles study design, organoid pre-screening and submission coordination.

Regulatory support
NMPA filing experience
Drug evaluation
ICH-series toxicology evaluation
Device evaluation
ISO 10993 biocompatibility evaluation
Front-end enhancement
Organoid pre-screening
Hub Logic

Why is GLP the platform's compliance hub?

GLP is the only compliance validation node that connects both drug compliance (ICH) and device compliance (ISO 10993). The two project types follow different testing standards, but both pass through the same GLP platform — unifying the valuation logic and solving the fundamental problem of merging drug and device pathways.

Drug Track
ICH S2/S5/S6/S7/S8/S9 · Acute/sub-chronic/chronic toxicology · Safety pharmacology · Reproductive toxicity
Device Track
ISO 10993 series · Cytotoxicity · Sensitization · Genotoxicity · Implantation evaluation
GLP front-end enhancement

Organoids: making GLP conclusions more credible

Organoid technology serves as a front-end pre-screening tool for GLP, filtering out ineffective candidate molecules before formal animal testing begins — significantly lowering failure rates and costs, while also supplying mechanistic data that supports GLP reports.

Front-end pre-screening Human-derived organoid models filter out ineffective candidates early, reducing unnecessary animal testing
Better prediction of human relevance Combining organoid data with GLP animal data improves the accuracy of predicting human toxicity
Mechanistic data support Adds mechanism-level evidence to GLP compliance reports, improving filing quality
Drug Safety Evaluation
Acute toxicity studies
Single-dose toxicity, LD50 determination, supporting ICH M3(R2) requirements
Repeat-dose toxicity
28-day, 90-day, and 6-month sub-chronic and chronic toxicology, NOEL/NOAEL determination
Genotoxicity
Ames test, mouse lymphoma assay, micronucleus test — the full ICH S2(R1) battery
Safety pharmacology
Core cardiovascular/CNS/respiratory battery, ICH S7A/S7B
Reproductive toxicity
Fertility, embryonic development, and perinatal toxicity evaluation, ICH S5(R3)
Carcinogenicity studies
Long-term dual-species (mouse/rat) carcinogenicity, ICH S1 series protocols
Medical Device Biocompatibility Evaluation (ISO 10993)
Cytotoxicity (ISO 10993-5)
Extract method, direct contact method, agar diffusion method, L929/CHO cell lines
Sensitization (ISO 10993-10)
Guinea pig maximization test (GPMT), Buehler test (BT)
Genotoxicity (ISO 10993-3)
Ames test, chromosomal aberration, in vitro micronucleus — device-specific battery
Implantation (ISO 10993-6)
Subcutaneous/intramuscular implantation evaluation, histopathological analysis
Service Process
01
Project assessment
Requirements discussion, review of existing data, compliance pathway planning
02
Organoid pre-screening
Front-end enhancement: human-derived organoid toxicity prediction, filtering out weak candidates
04
Report delivery
Safety data report package in CTD format
05
Regulatory coordination
Coordinating with regulatory filing teams to submit application materials
Start your GLP compliance validation project
An integrated compliance validation solution, from organoid pre-screening through regulatory filing

Who stands behind the evaluation work

GLP safety evaluation is carried out at an established national evaluation centre inside our own system.

Prof. Liao Mingyang
Head, Yangtze River Delta National Innovation Centre for Drug Safety Evaluation Technology

The in-system centre that carries out the platform’s GLP safety evaluation work is led by Prof. Liao Mingyang. His positions and recognitions are held at national evaluation and regulatory bodies:

Chief Scientist, NPRD
National Beijing Center for Drug Safety Evaluation and Research — Chief Scientist, concurrently QA Director since 2004
State Council Special Allowance
Recipient of the State Council Special Government Allowance
Regulatory review expert
New drug review expert for the national drug regulatory authority
Chinese Society of Toxicology
Council member; doctoral supervisor

What this means for your project: the GLP report supporting your submission is issued by an established national evaluation centre within our own system — you are not being handed off to a third-party lab. The platform handles study design, organoid pre-screening ahead of the GLP phase, and submission coordination.