Analytical Development & Pharmaceutical Consulting
The Pharmaceutical Development Institute (PDI) provides specialized analytical development, testing, and consulting services to support pharmaceutical research and drug development. Drawing on extensive pharmaceutical industry experience in analytical development, cGMP laboratory operations, method validation, and stability programs, our scientists provide practical, scientifically rigorous solutions to complex analytical challenges.
PDI combines industry expertise, advanced analytical technologies, and access to the University of Rhode Island’s research resources to help pharmaceutical and biotechnology companies advance their drug development programs efficiently and cost-effectively.
Analytical Method Development & Optimization
PDI specializes in the development of robust, fit-for-purpose analytical methods for drug substances and drug products. Our approach incorporates modern analytical development principles, including Analytical Quality by Design (AQbD), Design of Experiments (DoE), and the enhanced analytical procedure development concepts described in ICH Q14.
Our capabilities include:
- Analytical method development, evaluation, qualification, and optimization
- DoE-based method development and optimization using Fusion software
- Application of ICH Q14 principles to analytical procedure development
- Development and optimization of stability-indicating analytical methods
- Forced degradation studies to assess degradation pathways and method specificity
- Analytical method troubleshooting and performance improvement
- Analytical testing to support drug substance characterization and formulation development
Stability & Degradation Studies
PDI provides stability and degradation studies to support early-stage drug development, formulation optimization, and assessment of pharmaceutical product quality.
Services include:
- Accelerated and controlled-condition stability studies
- Forced degradation studies
- Drug substance and drug product stability evaluation
- Stability-indicating analytical method development
- Excipient compatibility studies
Investigation of degradation products and stability-related analytical challenges
Pharmaceutical Analytical Consulting
PDI offers specialized scientific and technical consulting informed by extensive pharmaceutical industry experience in cGMP analytical testing, laboratory management, method development and validation, and drug substance and drug product stability programs.
Our scientists work collaboratively with pharmaceutical and biotechnology companies to develop effective analytical strategies, solve technical challenges, and provide expert guidance for analytical activities performed internally or through contracted laboratories.
Consulting services include:
- Analytical development strategies and method lifecycle management
- Technical guidance on ICH Q14, ICH Q2(R2), and analytical method validation approaches
- Analytical method qualification and validation strategy development
- Independent technical review of analytical methods, protocols, and data
- Analytical method troubleshooting and investigation of method performance issues
- Technical support for analytical method transfer to contract laboratories
- Scientific guidance and collaboration with contracted testing laboratories
Stability study design, analytical strategy, and interpretation of stability data
Analytical Testing & Instrumentation
PDI maintains analytical instrumentation and pharmaceutical testing capabilities to support method development, product characterization, and stability studies.
Core capabilities include:
- High-performance and ultra-performance liquid chromatography (HPLC and UPLC)
- Gas chromatography (GC)
- Dissolution testing
- Disintegration testing
- Moisture determination
Controlled-temperature and humidity stability chambers
Advanced Analytical Capabilities Through URI Core Facilities
PDI’s capabilities are complemented by access to sophisticated analytical instrumentation and specialized scientific expertise through the University of Rhode Island’s shared research core facilities.
Depending on project requirements and facility availability, these resources provide opportunities to incorporate advanced analytical technologies, including:
- Liquid chromatography–mass spectrometry (LC-MS/MS)
- Gas chromatography–mass spectrometry (GC-MS/MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Advanced spectroscopic and chromatographic techniques
- Differential scanning calorimetry (DSC)
- Additional specialized analytical and materials characterization capabilities
By leveraging PDI’s pharmaceutical development expertise and URI’s broader research infrastructure, we can offer flexible, collaborative approaches to challenging analytical development projects.
Partner with PDI
Whether developing a new analytical method, optimizing a formulation, investigating stability concerns, or seeking expert technical guidance for work performed at a contract laboratory, PDI provides the scientific expertise and collaborative approach needed to support your pharmaceutical development program.
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