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.
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.