Fangda Pharmaceutical is a fully integrated pharmaceutical R&D contract research organization (CRO) that can provide comprehensive, science-based analytical research and development services from drug discovery to development, and is committed to providing high-quality services to pharmaceutical companies. Fangda Pharmaceutical provides a full range of product development services for generic and innovative drug companies to support registration applications for IND (New Drug Clinical Application), NDA (New Drug Marketing Application), ANDA (Generic Drug), and 505 (b) (2). 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 studies, Fangda Pharmaceutical has helped customers advance hundreds of compounds from the product development stage to commercialization. “China and the US have the same quality system” We have benefited greatly from operating in China and the US (the two largest CRO service markets in the world), and are able to seize business growth opportunities in both markets. “China and the US, the same quality system” is our only guideline for adhering to high quality standards. This practice ensures that our customers have the same quality standards, operating procedures, and systems in China and the US, while also facilitating their in-depth understanding of drug discovery and development regulations in both countries. This way of operating also allows us to be a partner for companies with multinational demand, supporting customers to submit registration applications to the US FDA and the Chinese NMPA at the same time. The services we provide Laboratory services to support drug discovery and development Drug Metabolism and Pharmacokinetics (DMPK) Drug safety and toxicology studies bioanalysis Chemical, 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 important components of our ability to establish long-term strategies and partnerships with key customers. A fully integrated CRO operates in a huge and growing market, particularly 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 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 needs Experienced management team
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