Quality & Regulatory
Quality & Regulatory
Home CDMO Solutions Quality & Regulatory

Quality is the fundament for product success and a crucial step in biopharmaceutical research and manufacturing.

We have established a professional quality assurance team in compliance with the national regulations and guidelines including ISO, GLP, and GMP. They will be responsible for the overall quality management to ensure your gene and cell therapy products meeting the quality standard.

Quality Assurance System
Document and Training
  • Document management and control: preparation, distribution, and retraction
  • Personnel training management: training plan, implementation, and appraisal
Archive Management
  • Documents archiving
  • Management of documents borrowing
Process Supervision
  • On-site process supervision
  • Deviation management, CAPA, OOS/OOT
  • Company-wide self-inspection, report formulation and rectification supervision
Product Administration
  • Drug registration and application supporting
  • External audit docking and management
  • Complaint and adverse reaction management
  • Recall of related products
Quality Evaluation
  • Establish a supplier management system and develop operation procedures for supplier evaluation and approval
  • Material and product release standards formulation
  • Deviation management
  • Change management
  • Retrospective analysis of quality
  • Ongoing stability inspection
Validation Management
  • Risk assessment, identification, and verification
  • Validation plan preparation
  • Facility and equipment validation and revalidation
  • Production process validation and revalidation
De-risk Your Regulatory Pathway

Regulatory requirements vary with the development process of your product.

At OBiO, we provide you with a comprehensive support and customized services related to regulation along the milestones of product commercialization. We have successfully supported clients to obtain IND clearance in China, the United States, and Australia. Leveraging our expertise and relevant experience in the field of gene and cell therapy, we will navigate you with different requirements of different national regulatory agencies to help you reduce regulation-related risks and accelerate the commercialization of products.

We will provide e-CTD ready CMC related documents writing and review for your submission:

  • Small-scale process research test record
  • Process validation report
  • Production batch records, production data reports, chromatography raw data, process regulations, batch production bills of materials, production liquid preparation records
  • Key quality control experiment records
  • Quality control method validation report
  • Environmental monitoring records
  • Material quality certificate and test reports
  • List of equipment operating procedures involved in the project
  • Material management ledger
  • Material management record
  • Equipment usage records
  • Equipment standard operating procedures
  • Personnel training and induction records
  • Gap analysis, technology transfer report, change report, risk assessment report, analysis method transfer report
Why OBiO?
High-standard and comprehensive quality controls
State-of-the-art facilities with cGMP compliant quality system
End-to-end regulatory support with side-by-side navigation
Quality-by-design in mind throughout the full product lifecycle
Successful support for distinguished clients with differentiated needs
Dedicated regulatory team with over 10-year experience in gene and cell therapy industry
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