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Compliance & Certifications
Compliance & Certifications
Our Commitment: Quality · Traceability · GMP Compliance
In the field of cell and gene therapy (CGT), quality and compliance are more than regulatory requirements—they are the foundation of trust and responsibility. At OranssiBio, we are dedicated to building a robust and integrated quality management system to ensure that every batch we produce is safe, consistent, and fully traceable—empowering our clients to advance clinical programs and regulatory filings with confidence.
GMP Certifications (China, US, EU)
We operate in full alignment with GMP standards and regulatory expectations from the NMPA, FDA, and EMA. Our flexible yet standardized manufacturing system includes:
- Multiple GMP-compliant production lines for viral vectors, plasmids, mRNA-LNPs, cell therapies, and exosomes
- ISO-classified cleanrooms (Grades B, C, and D) supporting aseptic processing
- Manufacturing capabilities spanning preclinical through commercial production
ISO 9001 Quality Management System
Our ISO 9001 certification enables end-to-end quality control, from raw material management to final product release:
- Well-established systems for document control and continuous improvement
- Regular internal audits and quality reviews
- Comprehensive SOPs covering all critical operations
Data Traceability & Batch Record System
We implement ALCOA+-compliant data systems to meet global regulatory and inspection requirements:
- Dual systems for both paper and electronic batch records
- Full traceability of raw materials, equipment, personnel, and key process parameters
- Transparent support for client audits and regulatory site inspections
Rigorous Intellectual Property Protection
We strictly safeguard client data and technical confidentiality through a robust IP protection framework:
- Mandatory NDAs and controlled access to sensitive zones
- Segregated storage of client documents to prevent data leakage
- Optional project exclusivity and dedicated team arrangements available
Support for Regulatory Filings in China, the U.S., and EU
With extensive experience in global CMC submissions, we provide tailored regulatory support across jurisdictions:
- IND / CTA / BLA modular dossier preparation
- Multilingual and region-specific documentation services
- Coordination with international consultants to facilitate global registration and communications
