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New Drug

SERVICE AREAS & COMPETENCES

Service Areas

Helping clients work out an overall scheme and plan to ensure compliance

Overseeing each research proposal generated and ensuring it is in accordance with the requirements of the overall design

Direction of the research direction, process, quality and budget in order to make adjustments quickly without losing time or money

Research and data coordination to ensure integration and compliance

Organization of milestone review and reporting to help clients in risk assessment

Management of sampling documents to comply with regulations

Ensuring IND packages meet CFDA requirements

Preparation of regulatory submission documents

Preparation for on-site inspections

Technical follow up to provide resolution to issues

WHY IS PRE-CLINICAL SUPPORT NEEDED?

Pre-Clinical development is a combination and coordination of Medicinal Chemistry, Process chemistry, Formulation R&D, Analytical R&D, DMPK, Pharmacodynamics, Toxicology, Regulatory and clinical preparation. Each of those areas are correlated in a complex matrix

Pre-Clinical development requires an overview of design, management and evaluation done systematically.We need to assure that the study is synchronized with its IND package study design and compliance with regulatory requirements (such as US FDA and CFDA and EMA). It is also required to achieve end points efficiently and cost effectively

Pre-Clinical development is a kind of one stop shopping service platform. It is based on our extensive pre-clinical service expertise in drug development at Sundia. We have offered our clients a comprehensive and one stop shopping service in pre-clinical development