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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.
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Service hours:9:00 — 18:00