Small Molecule CMC
Using our mature small molecule Chemistry Manufacturing and Control (CMC) preparation production service platform, we have provided small molecule drug projects to customers worldwide, including the research on the production process of bulk drugs, the quality of bulk drugs and production technology research services including stability research and innovative preparation research. The platform includes analytical testing laboratories, API/intermediate production research laboratories, QA/QC laboratories, and innovative formulation research laboratories.
Overall solutions
- CD BioSciences focuses on pharmaceutical process development and R&D manufacturing services.
- Our services include process R&D/chemical development, mass production of advanced intermediates, registered raw materials, cGMP manufacturing of API, formulation development, analytical method development, and verification of regulatory documents and CTD support.
- In order to better serve our customers, we have made major investments in multi-functional high-tech facilities for process research and development, chemical development and API manufacturing.
- We have many senior experts who have worked in major pharmaceutical companies in the United States and Europe for many years. We ensure that our customers are 100% satisfied with our services.
Platform hardware introduction
Pilot and commercial production workshops include oral liquid production line, volumetric injection line, oral preparation line, granulation and coating workshop, power center, storage center (finished product warehouse, packaging material warehouse, raw and auxiliary material warehouse, spare parts warehouse, shade warehouse, and consumables library). Our R&D facilities include positive control room, microbial limit room, sterile testing room, instrument analysis room, physical and chemical laboratory, endotoxin testing room, microbial preparation room, stability laboratory and QA archive room.
Our Service
|
Project name |
Small Molecule CMC |
| Service |
- Research on production process of API
- Research on the quality and stability of raw materials
- Innovative formulation research
- Process R&D Services
- Process Safety
- Analytical Development
- Pre-Formulation Development
- Formulation Development
- ICH Stability Studies
- CMC CTD Support
- Manufacturing
|
| Cycle |
To be decided according to your needs. |
| Product delivery mode |
Including final product delivery, electronic data report. In addition to the agreement, relevant electronic data will be provided together. |
| Price |
Inquiry |
Our advantages
- As a leader in the field of small molecule CMC, CD BioSciences can now provide professional services to our customers.
- Our mature technology platform can meet the needs of any type of new drug's research and development.
- High efficiency, fast response speed, flexible research direction, low price, short cycle and high quality.
- Customizable production services can help customers reduce capital and time costs.
Why choose us?
CD BioSciences' small molecule CMC is a personalized and customized innovative scientific research service. Each project needs to be evaluated before the corresponding analysis plan and price can be determined. If you want to know more about service prices or technical details, please feel free to contact us.
It should be noted that our service is only used for research, not for clinical use.
