Clinical Research Support

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 Drug Substance & Drug Product, 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 Small Molecule API DS & DP
Custom Synthesis, Preclinical Batch Preparation and GLP Characterization, Metabolite/Impurity Synthesis, Radiolabeled Chemistry

Contact

Aaron Heiss, Ph.D.
216-276-3559

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Featured Work

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…

Full suite of GLP/cGMP validated instrumentation

Analytical Chemistry

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

Bioanalytical Chemistry

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

Repository Management

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

Chemical Synthesis

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 9001:2015 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.