MRIGlobal provides a full suite of Analytical Method Development and Phase Appropriate Validation services to support the drug development process. We solve product development challenges including:
- Product registration and certification
- Performance failure and out-of-specification analysis
- Process development
Our highly-skilled analytical chemistry team brings years of experience, working across many types of products, methods, and analytical technologies to ensure methods are suitable for their intended use.
Our team excels in the earliest phases of drug discovery and preclinical development, through full cGMP method development and validation. MRIGlobal’s primary focus in pharmaceutical analysis support involves the development and validation of methods for the assay, identity, and purity of new pharmaceutical agents, including both bulk drug substances and formulated products. Methods are validated in accordance with FDA cGMP and ICH guidelines (e.g., Q2(R1)) as needed to meet our clients’ objectives. Stability studies can be performed on both the drug substance and drug product in accordance with ICH Quality Guidelines (e.g., Q1A(R2), Q1B, Q1D, Q1E, and Q1F). We also offer analysis and determination of concentration and identity of impurities or excipients present in the products.
While industry turnover remains high, MRIGlobal’s team boasts an average of 13 years of experience within our organization.
We take on the unusual and the challenging every day, analyzing the complexities of drug formation, identifying impurities, and more. That’s why we are energized and impassioned about your projects.