- Overview
- Our Capabilities
- Partnering with Us
Overview
In recent years, there has been a rapid advancement in the field of cell and gene therapy, offering promising treatment options for a wide range of diseases. However, as the complexity of these innovative products continues to increase, manufacturers face increasing challenges in responding to an increasingly complex regulatory environment and driving product launch.
We deeply understand the complexity and challenges of regulatory affairs in the field of cell and gene therapy. That's why we offer a comprehensive, one-stop solution for application and registration throughout the entire life cycle of your products. From the outset, our team of regulatory experts works closely with you to develop a tailored regulatory strategy that aligns with your product development goals and regulatory requirements. If you have any need, please do not hesitate to contact us.
Our Capabilities
CMC Documents Submission for Global Regulatory Compliance
Our team is highly skilled in the preparation of key CMC documents required for regulatory compliance in different markets such as China, the United States and Europe. Depending on the unique requirements of our customers, we provide Pre-IND, IND, BLA, and supplementary CMC document preparation services, and assist in submission processes across these regions.
Formulate Submission Strategies
We provide expert consultation in creating tailor-made submission strategies for our customers. Our team ensures not only compliance with all necessary regulations but also strives to minimize risk and reduce both time and cost for our clients.
Regulatory Consulting Services
Our company provides comprehensive consulting services, covering the entire product life cycle. These services ensure compliance with all relevant policies and regulations and provide ongoing support to respond to the evolving regulatory environment.
Support Registration Issues
We offer expert support in tackling issues faced during the registration process. By communicating effectively with industry experts and regulatory authorities, we address and mitigate challenges in the registration process. Furthermore, we carry out detailed feasibility studies for registration and assist in responding to any concerns raised by regulatory authorities.
Partnering with Us
By leveraging our integrated capabilities, clients can entrust us to manage their entire regulatory affairs journey seamlessly. From initial submissions to ongoing compliance management, we are committed to providing strategic guidance, expert support, and personalized solutions tailored to meet the unique needs of each client.