Regulatory CMC Support

Ticking all boxes – wold-wide

We provide well-versed regulatory service for clients, including consulting/strategic services, Scientific Advisory Meetings, preparing regulatory dossiers and support in agency communication/responses.

We have the capabilities and experience of IND/CTA and BLA/MAA/NDA dossier preparation (English, Chinese) and application worldwide with proven success. Our regulatory team have established a close working relationship with agencies in US, EU, Australia, China and other Asian countries and have comprehensive understanding and knowledge of competent authorities’ laws and regulations to provide strategic regulatory advices throughout the product development lifecycle.