Pharmaceutical Sciences | Test and Evaluation
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 client’s 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.
MRIGlobal provides method development, optimization, and phase appropriate validation for small and large molecules.
- Custom synthesis of stable isotopes, reference standards, and chemical impurities.
- Separation and isolation using applications of prep LC, high resolution mass spectrometry and specialty detectors (ELSD, CAD, PDA).
- Appearance, identification, purity, impurities, chiral purity (if applicable), residual solvents, water content, crystallinity and morphology, heavy metals, residue on ignition, thermal properties, particle size distribution, and microbial.
- Release/Acceptance testing is conducted per a QAU approved protocol after all the necessary methods have been validated as needed.
- Short-term stability testing per ICH guidelines including forced degradation.
- Long-term stability accelerated, intermediate, and real time; Typical time points at 0, 1, 3, 6, 9, 12, 18, 24, and 36 months.
- 25℃/60% RH
- 30℃/65% RH
- 40℃/75% RH
- Attributes: Appearance, assay, purity, enantiomeric purity, water content, crystallinity, and microbial testing
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.
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MRIGlobal looks forward to contributing our expertise where it matters most.
Use our Project Quote Tool to see if MRIGlobal can help advance your next project.