Pharmaceutical Sciences
MRIGlobal helps clients accelerate the bench-to-bedside process and quickly deliver new therapeutic drugs for clinical evaluation
Emerging pharmaceutical companies rely on us. We bridge the gap between drug discovery and commercialization, moving products through the complex investigational new drug application process. Work is performed in a highly regulated environment to ensure drugs are safe for patients based on rigorous method validation and stability testing. Services include GMP API synthesis, analytical method development & validation, drug product formulation, drug product manufacturing, and pharmaceutical stability and storage.
Capabilities
The MRIGlobal repository facility supports services necessary to maintain clinical drug agents, products, and specimens:
- GMP full-service repository — receipt, quarantine, test, release, store, aliquot, and ship
- On-site drug distribution license
- Worldwide distribution and cold chain management
- Ability to handle controlled substances (Sch 3-5)
MRIGlobal offers:
- Custom synthesis options and preparation of active pharmaceutical ingredient (API) in kilogram quantities suitable for Phase I studies
- Custom synthesis and characterization of high-purity reference standards to support analytical method validation and assays
- Services for custom isotope-labeled materials for bioanalytical applications to support toxicology studies
- Stability & storage
- Method development & validation
- Impurities isolation & identification
- Materials characterization & release
- GMP full-service repository—receipt, test, store, aliquot, and ship
- Clinical trial label design
- Customized clinical supply kits including placebo for blinded studies with over-encapsulation capabilities
- On-site drug distribution license
- Analytical support—identity confirmation and comprehensive API and drug product testing, including ICH stability testing
- Worldwide distribution and cold chain management; more than 1,500 investigational agents shipped
- Pre-formulation
- Formulation Development
- Over-encapsulation for blinded studies
- Packaging and Labeling
- Method development/transfer and validation,
including long-term stability and ISR, per FDA 21 CFR 58 & guidance documents - Analysis of biological samples generated by tox, DMPK, safety, and clinical studies, per FDA 21 CFR 58 & guidance documents
- Metabolite identification capabilities
- Custom synthesis support, e.g., cold-labeled IS
- Characterization (chemical and formulation)
- Formulation development, preparation, and analysis
- Qualified instrumentation and validated software
- Biological sample management capabilities
Featured News
Developing Investigational New Drug Applications
Pre-Clinical Data Supports Drug Clearance to Clinical Stage In brief, an Investigational New Drug (IND)… Read More
Work with us
MRIGlobal looks forward to contributing our expertise where it matters most.
Use our Project Quote Tool to learn more about how we can help with your next endeavor.