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One-Stop Solution for Biosafety with In-House Capabilities

BRC Biotechnology's Detection Platform is equipped with biosafety testing capabilities that integrate GMP standards, spanning a wide range of specialized domains, including molecular biology, microbiology, virology, cell biology, animal studies, immunology, and viral clearance. The platform adheres strictly to GMP, GLP, ISO, CNAS, and CMA standards, as well as Biosafety Level 2 (BSL-2) requirements. BRC Laboratories utilizes state-of-the-art equipment from leading multinational manufacturers, ensuring rigorous quality control and validation to meet 21 CFR Part 11 requirements for electronic signatures and data integrity. BRC Biotechnology has a proven track record, having passed audits from more than 100 global clients and successfully delivered over 100 IND/BLA submission projects to date.

BRC Biotech’s Compliant Quality System Ensures Regulatory Adherence

BRC Biotechnology establishes a robust biosecurity framework through an international quality compliance system. We strictly follow cGMP standards of China, the U.S., and Europe, implementing a quality management system that covers the entire biologic lifecycle—from sourcing GMP-grade raw materials and executing rigorous testing protocols to upholding the highest global quality benchmarks. Leveraging strong R&D capabilities and a comprehensive quality system, BRC Biotechnology is committed to providing professional risk assessments and customized solutions for clients, safeguarding biopharmaceutical security.

EU GMP Qualified Person (QP) compliance statement
United States FDA Facility Establishment Identifier (FEI)
ISO 9001: 2015
Biosafety Level 2 (BSL-2)
China Metrology Accreditation (CMA)
China National Accreditation Service for Conformity Assessment (CNAS)

EU GMP Qualified Person (QP) compliance statement

BRC Biotechnology Successfully obtains EU OP (Qualified Person) Compliance Certification, demonstrating full alignment of our quality management system with EU GMP requirements and validates our capability to deliver internationally compliant biopharmaceutical services to global markets. Leveraging rigorous scientific governance, an exceptional quality system, and a robust technical platform, BRC Biotechnology provides partners with regulatory-compliant professional solutions. We support global drug registration and commercial-scale production of biologics, accelerating the international expansion of innovative biotherapeutics.

United States FDA Facility Establishment Identifier (FEI)

BRC Biotechnology has officially obtained FDA authority oversight, effectively assisting global clients in meeting international regulatory requirements for biological products and satisfying FDA safety traceability The Facility Establishment Identifier is a unique number used by the FDA to identify businesses. Possessing an FEI number means the manufacturer must comply with FDA's quality control requirements and standards, including facilities, production processes, equipment, personnel, and documentation. Additionally, the FDA can track and regulate the manufacturer's products based on the FEI number to ensure they meet FDA's safety and efficacy requirements. Applying for an FEI number can make the sale of a manufacturer's products in the U.S. market smoother. Furthermore, a facility with an FEI number can use its certificate as evidence to demonstrate that its products comply with relevant U.S. regulations and standards. As a testing service provider with a global perspective, BRC has established a quality system that complies with GMP standards from China, the USA, and Europe, and has built a comprehensive lifecycle quality management system according to strict cGMP standards, covering data integrity (DI), computer system validation (CSV), and analytical method verification and validation, providing reliable and comprehensive support for client projects.

ISO 9001: 2015

BRC Biotechnology adheres to ISO 9001: 2015 Quality Management System Standards to ensure improved quality systems. ISO is a global standard developed by TC176 (Technical Committee on Quality Management Systems). The ISO 9001 Quality Management System certification standard is a summary of management theories and practices developed over many years in advanced countries, reflecting a management philosophy, quality management methods, and models that have been adopted by over 100 countries and regions. As a third-party testing laboratory, in addition to cGMP and pharmacopeia requirements, ISO 9001: 2015, as a global quality management system standard, is the most mature quality framework to date, setting standards for an overall corporate management system. BRC Biotechnology follows the ISO 9001: 2015 quality management system standard and has clear & explicit international certification quality.

Biosafety Level 2 (BSL-2)

BRC Biotechnology is certified for Biosafety Level-2 (BSL-2) regulations to ensure a comprehensive quality system. Biosafety Level-2 (BSL-2) laboratories handle pathogenic agents that pose moderate hazards to humans, animals, and the environment. These pathogens typically do not cause serious harm to healthy adults, animals, or the environment and can be controlled with effective prevention and treatment measures. Biosafety testing for biopharmaceuticals requires at least BSL-2 standards, suitable for sampling, testing, and research from unknown pathogenic vectors.

China Metrology Accreditation (CMA)

BRC Biotechnology complies with CMA certification to ensure a more comprehensive quality system. CMA (China Inspection Body and Laboratory Mandatory Approval) is a metrology certification authorized by the State Administration for Market Regulation, allowing testing organizations to use the CMA mark in their reports. This certification can be used for product quality evaluation and has legal effect, serving as the basis for acceptance by arbitration and judicial institutions. CMA certification ensures the maturity of management and data integrity in third-party testing laboratories, which are recognized internationally. Testing institutions in China must comply with the certification requirements set by the State Administration for Market Regulation.

China National Accreditation Service for Conformity Assessment (CNAS)

BRC Biotechnology complies with CNAS certification to ensure a more comprehensive quality system. CNAS (China National Accreditation Service for Conformity Assessment, China National Accreditation Board) is the official Chinese body responsible for the accreditation of laboratories and inspection bodies, designed to meet the needs of international mutual recognition of laboratory and inspection body capabilities in international trade. CNAS conducts assessments and accreditations based on international standards such as ISO/IEC 17025 to ensure the technical capabilities and management levels of laboratories and inspection bodies are accurate and reliable. Additionally, CNAS is responsible for regular supervision and re-assessments of these bodies to ensure ongoing compliance with accreditation standards and collaborates with international accreditation bodies to promote international mutual recognition, thereby enhancing the international competitiveness of Chinese laboratories and inspection bodies and facilitating international trade and technical exchanges. Test reports and certificates issued by CNAS-accredited laboratories and inspection bodies are widely recognized internationally.

Platform & Technologies