Discovery Chemistry /CRO

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.
 
Hit identification
Hit-to-lead discovery
Lead generation
Lead optimization
SAR development
Libraries synthesis for Lead compounds
Patent application preparation
Project management

Intermediates/CMO

  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).

 

CDMO Service

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.

 
Development and optimization of innovative process routes
Production of API/intermediates
Synthesis and manufacture of building blocks
Development and process optimization of preclinical candidate compounds
 
Process optimization of designated routes
Production of Special chemicals
GMP/Non-GMP production of intermediates
Synthesis of high-quality kg scale samples

CMC Registration Support

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.
Route Screening &process optimization of APIs
Study of complete impurities of APIs
Polymorph, salt and co-crystal screening of APIs
Crystallization processes of API and intermediate for scale-up, control of polymorph and particle size
Technical pack of intermediates support
On-site audit
IND/NDA/ANDA regular filling support

New Materials

Design, Process research and Development of New Materials

With the Strong R&D teams, LinkChem can provide custom service of design, process research and development of new materials including:

Lithium Battery Material
Photoelectric Materials
Semiconductor Materials
PI Monomer
Fluorine Materials
Noble Metal Catalysts

Commercial production of new functional materials and intermediates

Based 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.

Analytical Services

Quick analysis for new drug substance
Analytical support for process research
In process control and release test
Analytical method development, method validation and qualification
Elemental analysis and method development
Genotoxic impurity method development and validatio
Residual solvent method development and validation
Reference standard characterization and qualification
Impurity isolation, identification and characterization
Stability studies for drug substance