Our company provides a one-stop innovation platform that combines API and formulation for the creation of novel drugs. Our pharmaceutical CDMO offers cutting-edge R&D solutions in process chemistry, formulation, and large-scale production. The CDMO thoroughly and in-depth incorporates all stages of drug development, including preclinical research, clinical trials, and commercialization.
Our CDMO Service Platform
Our company is capable of handling the entire formulation development process, including project assessment, pre-prescription research, formulation process research, quality research, clinical sample production, stability research, etc. This aids in medication development on all fronts.
| Innovative Drug CDMO Services | Generic Drug CDMO Services |
- Pre-prescription studies (feasibility evaluation, dosage form selection, pharmacophore compatibility studies).
- Formulation process studies (formulation development, formulation process optimization and quality development).
- IND, Phase I clinical (pilot scale-up, quality studies and stability, Phase I clinical samples).
- Phase II/III clinical trials (process scale-up and changes, Phase II clinical samples, Phase III clinical samples).
- Confidentiality agreements (prescription process validation, quality studies, process validation).
| - Pre-prescription studies (raw material characterization, raw material compatibility, reference formulation studies and reverse engineering).
- Formulation process studies (QTPP, CQA, QbD, DoE, CMA, CPP, DS quality studies).
- Process scale-up (CQAs, CPPs, in vitro and in vivo consistency and stability studies).
- Analytical methods and process validation.
- Marketing applications (process validation, application materials).
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Dosage form development:
- Oral preparations (tablets, capsules, granules, oral liquids/mixed suspensions, syrups).
- Injections (injection, sterile powder for injection, injection solution).
- Topical preparations (ointments, creams, tinctures).
- Other preparations (eye drops, sprays, inhalants, extended-release agents).
Advantages of Our company's CDMO Platform
Comprehensive Optimization
Our CDMO platform can fully optimize R&D projects from several viewpoints, such as medicinal chemistry, physicochemical characteristics, and pharmacokinetic/pharmacodynamic (PKPD), thanks to our innovative technological platform, deep R&D experience, strict quality system, and rigorous IP protection.
Cost Control
By reducing the time and costs associated with trial period product modification, our CDMO services enable customers to flexibly transfer capacity pressures.
Complete Laboratory Facilities and Multi-functional R&D Base
We have QC labs that follow GMPs, analytical labs, R&D labs, microbiological labs, and other bases. To successfully finish the drug development projects for our customers, we have the most cutting-edge instruments and laboratory equipment.
Continuous Innovation of Technology
We have continuously increased our expertise in the area of biomolecules in addition to our well-established abilities in chemical medication development. Systems for the research and manufacture of antibodies and tiny nucleic acid medicines have been established. Additionally, we have improved and innovated our quality research methods, process safety studies, and technologies for screening salt and crystals.
For more information, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
