Analytical Development and Testing Services
CuriRx provides a full range of analytical development and testing services to pharmaceutical and biotechnology companies to support both drug development and manufacturing.
As drug product pipelines are becoming more complex and challenging, there is an increasingly need for sophisticated instrumentation and technologies to accurate detail critical quality attributes. CuriRx utilizes a wide range of advanced instrumentation and technology to assist our clients in solving the most challenging analytical problems for both large and small molecules, from R&D projects to clinical phase release testing and stability studies.
CuriRx’s subject matter expertise covers a wide range of analytical methodologies, allowing for NDA, BLA, ANDA, 505(b)(2), biosimilar characterization, analysis of all antibody CQAs, characterization of impurities, and identifying manufacturable drug candidates.
We believe in a best-practice approach for analytical development; this involves orthogonal techniques that are sensitive, accurate, and linear over a broad concentration range for therapeutic molecules. Molecular characterization also plays a centralized role in developing specific analytical methods for testing purity, consistency, identity, and quality of your drug product. We offer phase-appropriate method qualification and validation to support clinical development, regulatory submission requirements, or your ongoing quality control needs.
At CuriRx, our analytical development and testing services group is focused on providing high-quality testing service and customer satisfaction. Our professional staff provide fast, dependable, and accurate results.