Fonda Pharmaceutical Technology (Shanghai) Co., Ltd. () was established in early 2006, which is the first GLP laboratory established and operated according to FDA standards in China. Fonda Pharmaceutical Technology Co., Ltd. established China Clinical Research Branch of Fonda Pharmaceutical Technology (Shanghai) Co., Ltd. on the basis of the merger of leading biomedical research companies in the United States, with Shanghai branch as the forefront and company headquarters as the backing.
Fonda's leading pharmaceutical companies need to solve the problems in drug research and development, improve their drug products and obtain FDA approval; Cooperate with domestic pharmaceutical companies to promote FDA approval of raw materials and generic drugs to enter the international market; Provide a dynamic working environment for employees, with high-quality talents and advanced technology as the main resources. Chemists, pharmacists and chemical engineers with high education and rich experience in industrial drug research and development.
● Rich experience in drug research and development in pharmaceutical companies such as Pfizer, Wyeth, GlaxoSmithKline, Aventis and Lilly.
● The company's scientists have experience in all stages of drug development-the discovery, development, clinic, verification and listing of brand drugs and generic drugs.
● Having worked in cGMP/GLP laboratories or factories for many years, Fonda's malvin laboratory is the first laboratory established in China according to the requirements of GMP and GLP of FDA, providing scientific research services that meet FDA standards for international pharmaceutical enterprises. The laboratory passed the FDA inspection and won favorable comments. The laboratory of Fonda Shanghai Company is also established according to the GMP and GLP requirements of FDA. Instruments and equipment, cGMP/GLP management According to the mature laboratory construction and cGMP/GLP management mode of the head office, there are experienced experts and cGMP/GLP training for employees.
Service items ● Overview
Start with a reliable preclinical project until it is approved by the US Food and Drug Administration. From the design of the research plan to the final declaration, Fangda scientists and technicians are ready to help you and your drug development project in all aspects.
An experienced team of experts, using the most advanced equipment and cutting-edge technology, conducted ADME research in vitro. The research contents include: metabolic stability research, metabolic pathway identification and metabolite identification and analysis; And CYP450 analysis, protein binding and water solubility test.
Other research projects of Fonda Lab include:
Toxicological study
Toxicological identification
histopathology
Safety pharmacology research
In vivo preparation verification and pharmacokinetics study
After the pre-clinical research is completed, Fonda's technical and regulatory experts will further develop your drug products from the pre-clinical research stage to the clinical development stage, and help them obtain the approval of the regulatory authorities through the review and evaluation of technical documents and pre-clinical data. Fonda's team will help you prepare for the expert Committee meeting of the US Food and Drug Administration and attend the meeting as a technical consultant on behalf of customers.
●GLP toxicology study
● ADME study in vitro
● Pharmacokinetic study
● Safety pharmacology
● Technical and legal affairs consulting business ● LC/MS&; Development and Verification of Gas Chromatography/Mass Spectrometry
● Clinical biomarker and immunogenicity testing services
● Development and validation of biomarker analysis
● Pharmacokinetics and pharmacodynamic model
● Pipeline sample management and processing
● Technical and regulatory affairs consulting business ● Overview
When the pharmaceutical project advances from preclinical stage to clinical research and development stage, Fonda needs to conduct a comprehensive analysis, preparation and detection of your raw materials or organic compounds monitored in vivo. Fonda's CMC services include customized analysis and research and development of APIs, reference standard services to support the research and development of finished drugs to determine appropriate dosage forms, and dosage form analysis, dosage form analysis, stability analysis and dosage form analysis of other physical and chemical substances through analysis services.
Fangda's cGMP production equipment is mainly used to produce oral solid preparations, semi-solid, liquid and sterile products. From the production of a small amount to 120 kg of solid preparation, 350 kg of semi-solid, liquid and aseptic operation can reach 100 liter.
In addition, the technical and regulatory consulting team can provide you with professional help in handling matters related to INDs, NDAs and ANDAs documents of the US Food and Drug Administration. In addition, the professional team can help you complete the technology transfer of analytical methods and R&D processes.
● Research and development of finished drugs
●GMP raw material production and organic synthesis
●ICH stability storage and testing
● The consulting business of technical and legal affairs companies provides a wide range of clinical services, thus making drug development projects at the leading level;
Clinical experiment design, experimental scheme and regulation consultation, project management, clinical monitoring, clinical data management, biostatistics analysis, pharmacokinetics and pharmacodynamics analysis, audit quality assurance, medical document writing, patient recruitment and regulation consultation. The clinical research professionals of Fonda Company have successful experience in managing clinical I-II A trials and international multi-center trials in North America and China. Clinical trials of new drugs and generic drugs were successfully conducted in 72 beds in Hackensack, New Jersey, USA and 130 beds in Zhengzhou, China.