Precise verification system enables compliant implementation of biological detection methods.
HyQure Biotech delivers end-to-end method validation, verification, and transfer services aligned with the latest regulatory standards. From rapid molecular assays to complex biological detection, we ensure your analytical methods are robust, traceable, and audit-ready.
We develop specialized technical service strategies, creating customized solutions for clients with specific testing and method development needs.
|
Regulatory Alignment: In accordance with the 2025 edition of the Chinese Pharmacopoeia, General Chapter 9101 Analytical Method Validation Guidelines and General Chapter 9100 Analytical Method Transfer Guidelines, HyQure Biotech supports the custom design, optimization, and validation of rapid molecular assays (RMM), and transfer of assays to routine quality control laboratories.
|
Service Core
We offer customized validation and verification protocols to meet the needs of qualitative/quantitative analysis, impurity control, and content and potency determination of biological samples, covering the entire process from protocol design, experimental execution, result evaluation, and anomaly tracing.
Protocol Design
Define the purpose and target audience, and determine the indicators, standards, and instruments/reagents
Experimental execution
Complete recording of raw data, calculation process, and graphs with full laboratory documentation.
Results Evaluation
Determine whether the method meets the intended purpose by comparing it with the standard.
Anomaly tracing
Record anomalies and the causes of deviations to form a closed-loop report.
RMM Validation & Transfer Roadmap
Preliminary Communication
Clarify client requirements, define project scope, and establish regulatory and technical expectations for the assay.
Method Development
Customized method development with issuance of a comprehensive development report documenting all parameters.
Method Validation
Customized method validation with issuance of a validation report demonstrating fitness for intended purpose.
Method Transfer
Method transfer completed based on client requirements, enabling seamless integration into routine QC laboratories.
|
Stage |
Scope of Work |
|
Phase 1 |
Preliminary communication to clarify client requirements. |
|
Phase 2 |
Customized method development with issuance of a development report. |
|
Phase 3 |
Customized method validation with issuance of a validation report. |
|
Phase 4 |
Method transfer can be completed based on client requirements. |
Core service advantages
Compliance and Adaptation
Meets regulatory requirements and facilitates project application across FDA, EMA, NMPA, and ICH frameworks.
Customized solutions
Validation strategies tailored to different samples and needs, from cell banking to viral clearance and potency assays.
Data traceability
The entire process is recorded and audited, ensuring that results are traceable and reproducible for regulatory submissions.
Comprehensive technology
Relying on core technology platforms, we solve complex testing challenges including qPCR, STR, COI, and TEM workflows.