Fangda Pharmaceutical is a fully integrated pharmaceutical research and development contract research organization (CRO). It can provide comprehensive, science-based analysis, research and development services from drug discovery to development, and is committed to providing high-quality services to pharmaceutical companies. Fangda Pharmaceuticals provides a full range of product development services to generic and innovative drug companies to support IND (New Drug Clinical Application), NDA (New Drug Marketing Application), ANDA (Generic Drug), and 505 (b) (2) registration. We work closely with our customers to ensure an in-depth understanding of their drug development goals to provide flexible solutions to meet the needs of each customer; we follow strict science, technology and quality systems to ensure the high quality and compliance of every project. From new drug feasibility studies to clinical research, Fangda Pharmaceuticals has helped customers advance hundreds of compounds from the product development stage to commercialization. “China and the US, same quality system” We benefit greatly from operating in China and the US (two of the world's largest CRO service markets), and are able to seize business growth opportunities in both markets. “China and the US, same quality system” is our sole principle of adhering to high quality standards. This approach ensures that our customers have the same quality standards, operating procedures, and systems in China and the US, while also providing customers with an in-depth understanding of the regulatory requirements for drug discovery and development in both countries. This mode of operation also enables us to become a partner for companies with multinational needs, supporting customers to submit registration applications simultaneously with the US FDA and the Chinese NMPA. The services we provide Laboratory services to support drug discovery and development Drug Metabolism and Pharmacokinetics (DMPK) Drug safety and toxicology research biological analysis Chemistry, Production, and Control (CMC) Agrochemical services Services related to supporting clinical research Early clinical services Biomarker services The value we provide We are a high value-added partner focused on solving our customers' most important and complex drug discovery and development challenges. Our scientific knowledge base, technical expertise, and reputation for excellent service are an important part of our ability to establish long-term strategies and partnerships with key customers. A fully integrated CRO operates in a huge and growing market, especially in China, which can make good use of strong industry growth trends. It has a large number of experienced scientists and world-class facilities and equipment, and is capable of providing value-added technical services. Strict quality management system and excellent compliance and traceability records Has extensive experience in expanding the customer base and establishing long-term stable partnerships with customers Flexible and efficient submission of complete deliverables according to customer requirements Experienced management team
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