Ensure product safety, efficacy, and regulatory compliance with Element’s comprehensive pharmaceutical quality control services for raw materials, active pharmaceutical ingredients (APIs), intermediates, excipients and finished products.
Our consultative, expert scientists provide full analytical development and validation in support of all phases of product and process development, from raw material testing to commercial batch release. Our GMP-compliant and FDA-registered laboratory facilities are fully equipped with a wide range of advanced instrumentation and support a complete offering of analytical outsourcing solutions, including failure analysis, problem-solving, and extractable and leachable testing at any stage of product development.
Quality control testing services
- Analytical method development and validation
- Compendial and monograph testing (USP, EP, BP, JP & ICH)
- Method verification
- Raw material testing
- QC testing of excipients
- In-process sample analysis
- Finished product, batch, and lot release testing
- Stability studies, including ICH stability testing and storage
- Photostability studies and photodegradation
- Forced degradation studies
- Impurity and contamination analysis
- Cleaning validation and environmental monitoring
- Extractables and leachables (E&L) studies
- Analytical support for all stages of CMC development
- Analytical trouble-shooting
- Technology transfer
The Element advantage
Our goal is to help you successfully navigate the product development lifecycle and satisfy regulatory standards to bring the highest quality, most efficacious products to market quickly and efficiently. Whether it is for compendial testing or the development and validation of phase-appropriate analytical methods, Element’s flexible, customized, and comprehensive testing quality control testing programs are key to ensuring the success of your final product.
To learn about our pharmaceutical quality control testing services, or to speak with one of our experts, contact us today.
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