Our company is committed to providing one-stop pharmaceutical preparation services to our customers. We can undertake the whole process of formulation development and innovation from project evaluation and approval, formulation process research, quality standard establishment and research, clinical sample production, safety evaluation, etc., to meet all the needs of our customers for formulation development services.
Service Overview
Our company has a specialized technology platform for innovative drugs. We are committed to delivering contract research and development services for solid, semi-solid, liquid, and novel formulations. Our one-stop, systematic formulation development services can suit our customers' R&D demands at different stages.
We have developed and implemented technologies that can address common solubility and permeability issues with new therapeutic candidate molecules. These technologies include solid dispersion, micronization, solubilization, encapsulation, and integrated in vitro dissolution/in vivo pharmacokinetics (PK) evaluation. We also have extensive experience developing microparticle formulations, protein and peptide medication formulations, sustained and controlled release formulations, and have successfully delivered a number of mature products to our customers.
Our main services are listed below.
Research Capabilities
- We provide a wide range of chromatographic techniques (HPLC, UPLC, GC, IC) and assays (UV, MS, MS/MS, ELSD, FID, fluorescence) to suit different types of compounds.
- We provide analytical and detection methods for the content and/or related substances of raw materials and pharmaceutical preparations.
- We can also provide other special assays, such as solubility (IR, ER, MR), solvent residues, genotoxic impurities, enantiomeric separation, ion chromatography, microbial detection, etc., as well as method development experimental design and progress reports, method validation plans and validation reports.
- We provide comprehensive services such as scheme design for stability research, project management, stability sample storage and testing, data trend analysis, and drug shelf life evaluation.
- We can further integrate with preclinical toxicology research, clinical research, and drug administration services to provide a full range of services.
- We can realize small tests for oral, injectable, topical and various formulations, and are equipped with small test equipment corresponding to each dosage form.
- For oral solid formulations, we can prepare pilot scale-up related documents, materials, etc., after we have completed the production of formulation small trials and confirmed that the prescription process is feasible and the initial stability of samples is good.
- In order to better meet our customers' needs for one-stop services for formulation development, we have established a GMP-compliant oral solid formulation workshop, which can perform raw material crushing, weighing, mixing, granulation, drying, whole granulation, tablet pressing, capsule filling, coating and packaging, etc., while enhancing the level of pharmaceutical production and quality management system.
If you want to know more about service details, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
