What We Do

• All regulatory related consultations and submissions, including , drug development plans, consultation meetings, clinical trial applications and life-cycle management, marketing authorization applications and license life-cycle, common technology document preparation and submission, and due-diligence
• We provide regulatory expertise combining local experience with global standards for non-clinical, CMC, regulatory operations/registration and strategy to expedite a product's journey through the Clinical Development Pathway to market.

Our Capabilities and Strengths:

• The core regulatory team with average 18 years' experiences across global and Chinese lifesciences companies.
• Strong local and global expertise due to broad experience completing non-clinical, CMC, regulatory operation/registration and strategy throughout the product development cycle.
• Our accumulated practical experience supporting regualtory consulttions for innovative, generic, and biosimilar drugs in China, APAC and US/EU has led to ongoing repeat business.