- Overview
- What We Offer
- Why Partner With Us
Overview
Our company is your trusted partner. We are committed to providing accurate, reliable, and compliant analytical development and quality testing services to support your drug development efforts and ensure the safety and efficacy of your pharmaceutical products. In addition, we understand the complexities of new drug development, drug CMC filing, and manufacturing release. No matter what problems you encounter at these critical stages, you can always contact us for help. We look forward to working with you!
What We Offer
Genotoxic Impurity Research
- Speculation of potential genotoxic impurities
- Development and validation of genotoxic impurity detection methods
- Control of genotoxic impurity levels
- Toxicology data query
- Sample detection
Structure Characterization and Impurity Analysis
- One-stop structural characterization and impurity analysis
Microbiological Testing
- Microbial limit test
- Bacterial endotoxin test
Analytical Method Development and Validation
- Development and validation of a method for quantitative determination of genotoxic impurities
- Development and validation of a method for the determination of heavy metal impurities
- Development and validation of a method for the determination of residual solvents
- Development and validation of solubility determination method
- Development and validation of a method for the determination of contents and/or related substances
- Experimental design in method development, process report, validation method and validation report
Why Partner With Us
Expertise and Experience
Our experienced technical team provides quality solutions and strategic guidance throughout the drug development process.
Comprehensive Support
From methodology development to regulatory submissions, we provide comprehensive technical support to ensure the success of your drug development efforts.
Regulatory Compliance
Our analytical development and quality testing services are designed to meet the stringent requirements of regulatory agencies worldwide, including the FDA, EMA, and ICH guidelines.
Tailored Solutions
We understand that every drug development project is unique. Therefore, we offer customized solutions to meet the specific needs and goals of each client.
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