Nanchang Blotting Technology Ltd., Co. is a regulatory affairs and science consulting firm. We help clients identify and solve regulatory science and affairs challenges to facilitate pipeline development, product launches and commercial business support.
1. We help foreign enterprises, China domestic companies, and research institutes apply for China biotech approvals.
2. We work with multi-national consultancy company, help China domestic companies and research institutes deregulate biotech products globally.
Our faculty is consisted of colleagues from MNCs, having more than 10 years of experience in China GMO regulation. From this experience, our team have successfully obtained and managed approvals of many of the most successful agricultural biotechnology traits in China. Most importantly, we have deep understanding of GMO regulations in China, and keep following up with GMO regulation evolution.
Our current activities involve clients in the United States, Brazil, Australia and China, specifically help with Ag-GMOs and gene-editing products deregulation. One example, we have successfully obtained approval for production trial for a local client, after the first and only submission, which speed up project progress and surpass competitors. Through our vast experience, large network with academic scientists and contract laboratories, we enabled our clients to understand the latest updates of regulation, meet China data requirements and therefore, timely obtain approvals.
We use a tailored, product-by-product approach to work with biotech companies in regulatory strategy, regulatory science and affairs. Helping our clients to understand their situation in the context of China GMO regulation is the critical first step and the basis for regulatory strategy. Then a gap analysis is conducted to discover the gaps between client’s data package and official data guidelines and precedents. After or during the gaps being filled, a series of stakeholders engagement activities will be launched to communication with key stakeholders. With having necessary data, information and study reports, we will prepare and submit dossiers with high standards.