Element’s analytical development testing and pharmaceutical quality control services ensure product performance and regulatory compliance.
Our experienced team of analysts provides full analytical development and validation in support of all phases of product and process development, from raw materials to commercial batch release. Our pharmaceutical quality control services ensure the safety and quality of your product at each stage of the analytical development and give you the certainty that all relevant regulatory standards are met.
From our analytical laboratories, which are Good Manufacturing Practice (cGMP) compliant and FDA audited, our experts provide a complete suite of analytical development services and quality control testing, including:
- Raw material testing
- USP/EP compendial testing
- Commercial release and stability testing
- Forced degradation studies
- ICH methods development and validation
- ICH stability testing and storage for drug substances and finished products
- Development and validation of dissolution methods
- Development and validation of methods for cleaning
- Analytical support for all stages of CMC development
- Analytical trouble-shooting
- Technology transfer
Working with us
Our unique combination of high-quality science and advanced technology is central to our offering in all phases of the product development and manufacturing process. Our goal is to help you meet the appropriate quality at each stage and satisfy regulatory standards to bring your product to market.
Whether it is for compendial testing or the development of specialized analytical methods for drug substances, Element’s scientists have the expertise to get your product through a comprehensive testing program that is key to ensuring the success of your final product.
To learn more about our analytical development and pharmaceutical quality control testing services, contact us today.
More from Element
Elemental Impurity Testing and Analysis
Element’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the safety of drugs and drug products.
NMR spectroscopy in pharmaceutical analysis enables identification of substances and impurities, verification of chemical synthesis and compound characterization, supporting critical stages of pharmaceutical development.
Residual Solvents Testing – USP 467 and ICH Q3C
Element’s residual solvents testing services per USP 467 and ICH Q3C ensure product quality and safety.
Pharmaceutical Unknown Identification and Impurity Testing
Our experts are experienced across a range of pharmaceutical impurity testing and contaminant analysis, from elemental impurities to extractables and leachables, supporting the safe development of new products.