OBiO Tech, Inc.

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