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Pharmaceutical Sciences

Customized Solutions for Product Development Challenges

MRIGlobal helps pharmaceutical clients accelerate their timeline and reduce the risks of getting a product to market by providing customized solutions to their product program. We bring a long history of diverse technical and regulatory expertise as well as a legacy of integrity and collaboration to make certain each project achieves its objectives—on time and on budget.

  • Analytical Method Development and Phase Appropriate Validation for API DS & DP, Intermediates, and Impurities
  • Bioanalytical Method Development and Validation, and Sample Analysis for Analyte Quantitation in Multiple Species and Matrices
  • GLP and cGMP Stability and Storage of Biological Samples and I DS & DP
  • Custom Synthesis, Preclinical Batch Preparation and GLP Characterization, Metabolite/Impurity Synthesis, Radiolabeled Chemistry

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Featured Work

Analytical Method Development and Phase Appropriate Validation

Analytical Method Development and Phase Appropriate Validation

Objective: Pain-Relief Product–Development and Validation for Two Formulation Methods—one for a Low Dose and Higher…

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Full suite of GLP/cGMP validated instrumentation

  • Experts with Small Molecules
  • Expertise in Characterization of Large Molecules
  • Fully Equipped Labs to Identify Products, Intermediates, Metabolites, and Impurities
  • Product Registration–Batch and Physical/Chemical analysis support
  • Method Development and Phase-Appropriate Validation
  • Pre-formulation and Development and Analysis
  • Characterization of Materials to Support Toxicology
  • ICH Stability Studies
  • Skilled in Handling Drugs of Abuse, Environmental Contaminants, Investigational Drugs, APIs, Small Molecule, Peptide, and Proteins
  • Over 50 Years’ Experience with Method Development, Optimization, and Validation
  • Short- and Long-Term Stability Testing
  • Quantitative Analysis in Various Biological Matrices
Four Decades of Repository Support for cGMP and non-GMP Materials

 

Facilities

  • 10,000 Square Feet of Secure Storage Space
  • Validated and Temperature Mapped Storage
  • −150°C; −80°C; −30° to −10°C; 2° to 8°C Refrigerator; Ambient AmegaView Continuous Monitoring and Alarm System
  • Inert Fire Suppression System
  • On-site Pharmacy and Pharmaceutical Distribution License
  • High Potency Containment Areas for Handling
  •  Potentially Toxic Materials
  • Automated Back-Up Generator to Support the Entire Facility in the Case of a Power-Outage

Support and Experience for Your Products:

  • Analytical Support—Identity Confirmation and Comprehensive API and Drug Product Testing, Including ICH Stability Testing
  • Worldwide Distribution and Cold Chain Management
  • Repository for NCI’s Oncology Portfolio of >6,500 Compounds
  • Repository for NCI DCP Chemoprevention Agents
  • GLP or non-GMP API & Intermediates up to kilo scale
  • Custom Synthesis & Route Selection
  • Reference Standard Preparation
  • Metabolite & Impurity Synthesis and Identification
  • Radiolabeled Chemistry (14C)
  • Stable Label Chemistry (13C, 2H, 15N)
  • Experience with Complex Chemistry
    (Conjugates, Steroids, Oligosaccharides)

Regulatory Compliance

  • FDA-Inspected
  • Independent Quality Assurance Unit (QAU)
  • FDA GMP and GLP Compliant (21 CFR 210/211 and 58)
  • ISO 9001:2008 Certified

Ask About MRIGlobal's Other Pharmaceutical Sciences Programs

  • Reference Standard Management Program
  • Clinical Trial Materials Management Program
  • cGMP Material Aliquoting, Repackaging & Relabeling
  • IND Enabling Program

Quality Assurance for Every Project

Our QA program, administered by an independent unit within MRIGlobal, is an integral part of all project work. We ensure continuous improvement through corrective and preventative actions, internal audits and client satisfaction surveys.