南宫NG28

Service Background

Chemistry, Manufacturing, and Control (CMC) services for preclinical drugs refer to comprehensive research and services on drug synthesis and formulation, production process, quality control, etc. Before the drug enters the clinical trial stage to ensure the safety, effectiveness and quality control of the drug. These services are crucial to drug development because they provide a foundation for the clinical trials and eventual marketing of the drug.

Preclinical CMC service for drugs

CTI Pharma and Medical Service provides you with professional preclinical CMC services for drugs. It has an advanced pharmaceutical testing platform and an experienced experimental team. It is committed to ensuring the quality and safety of drugs; promoting the development and technological innovation of the pharmaceutical and health fields.

Service scope

1.    Pharmaceutical Formulation: Pre-formulation research, Formulation research, Formulation reverse research (excipient determination and process route), supplementary application
2.    Drug synthesis: generic drug/new drug process development, customized synthesis, synthesis process and amplification, FTE service for new molecules
3.    Quality research: impurity detection method development, impurity customization and preparation, impurity conversion and removal, antibiotic polymer research
4.    Registration declaration: Raw material DMF, chemical drug registration declaration
5.    MAH service: apply for B certificate or drug registration approval for customers

Service items

1. Raw material CMC research service
● Impurity preparation, custom synthesis
● Generic drug registration application
● Impurity reprint and removal
● New drug IND and NDA
● Custom synthesis
● Process route development

2. Formulation CMC research service
● Eye drops, lyophilized formulation, Intralipid, liposome injections and other complex Formulation
●Development and registration application for Oral ordinary solid formulation and sustained-release formulation.

Service objects

1. Pharmaceutical manufacturers: generic drug and innovative drug companies;
2. Contract research organizations (CRO): provide impurity research and reverse phase research services for CRO companies.
3. Certified pharmaceutical sales institutions: scientific research institutions engaged in basic and applied drug research.

Technology platform and research

1. Instruments and equipment
Thermo Fisher Scientific Orbitrap Fusion Lumos
Thermo Fisher Scientific  Orbitrap Q Exactive HF
2D-HPLC-Q-tof
AB SCIEX LC-MS/MS 7500
AB SCIEX LC-MS/MS 5500+
Agilent GC-MS 8890-5977B
Thermo iCAP-RQ ICP-MS

2.Technology research
two-dimensional liquid chromatography-mass for impurity research;
Deuterated drug synthesis
Carbohydrate microchip technology platform

Our advantages

✓ Raw material registration and declaration, high-difficulty drug synthesis, deuterated drug synthesis;
✓ Drug quality research, especially impurity research and complex development
✓ Injections and Intralipid of complex injections
✓ Development of freeze-dried preparations and development of sustained-release preparations

Service process