| Our Discovery Services covers the entire spectrum of early-stage research from target identification to delivery of drug candidates for further development. We have experienced team of medicinal chemistry and organic chemistry experts to support our customers’ need for hit identification, lead generation lead optimization programs. | |
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As an experienced commercial manufacturer, LinkChem can provide one-stop outsourcing intermediates services of process route development and verification, analysis method development and verification, process improvement and application registration to help customers with investigational to commercial-scales developments. The development services include a large number of raw materials, registered starting materials and GMP advanced intermediates throughout the entire drug development process. With our strong and diverse infrastructure, LinkChem facilities are multipurpose and flexible and allow a rapid response to meet customer requirements. LinkChem have the advantage in the field of Heterocyclic Chemistry, chiral drugs, Carbohydrate chemistry, Nucleoside chemistry, Peptide Chemistry and Antibody Drug Conjugation (ADC). |
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LinkChem’s factory workshop has good versatility, flexible capacity of rapid switch and project management mode to ensure that the production and operation system can quickly and high-quality delivery of products and services required by customers. Relying on the international standard quality system and large-scale commercialized GMP product production experience, we can provide customers with high quality commercialized API and GMP intermediate products at the optimal cost, and provide customers with a series of additional services such as secondary process development and optimization. LinkChem has different types and different sizes of plants, which can achieve the perfect combination of laboratory scale to commercial production scale and ensure the stability of supply. |
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| LinkChem has a highly experienced regulatory affairs team which provides CMC services at all research stages of Investigational New Drug application (IND) and its clinical trial phases (P1, P2, P3), New Drug Applications (NDA), Abbreviated New Drug Application (ANDA), and post-approval regulatory services including product change, annual report and re-registration service. LinkChem establishes standardized management system to ensure the authenticity and professionalism of the data, to assist the drug regulatory department verification. With profound professional knowledge in synthesis, QC, QA, domestic and foreign policies and regulations, registration and rich industry resources, we provide domestic and foreign customers with high efficiency and high quality drug registration and declaration services in accordance with the requirements of laws and regulations. |
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Design, Process research and Development of New MaterialsWith the Strong R&D teams, LinkChem can provide custom service of design, process research and development of new materials including:
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Commercial production of new functional materials and intermediatesBased on a sound production system supporting by Fujian plant, Shangdong plant and Jiangxi plant, LinkChem Co.,Ltd. can support production of new materials and intermediates. Fujian plant can make use of local abundant fluorine resource and raw materials easily available, and are especially suitable for development and production of fluorinated functional materials LinkChem can provide customers with all kinds of new materials project industrialization. |
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