Reference Standard Management
Qualification and management to ensure reference standards are always maintained in a qualified state
Consistent Analytical Accuracy
Regulatory compliance and product characterization require high-quality, well-characterized reference standards to ensure accuracy, consistency, and traceability. Managing these materials can be complex and resource intensive. MRIGlobal helps reduce risk, strengthen regulatory readiness, and support confident decision-making throughout drug development.
Ensuring Qualified Reference Standards
Synthesis
Utilize analytical and synthetic chemistry expertise to produce well-characterized materials.
Qualification
Ensure consistent availability of qualified standards to support drug development and regulatory compliance.
Storage & Distribution
Provide centralized, cGMP-compliant storage, secure inventory management, and global distribution.
Centralized Management
Coordinate qualification, testing, inventory, and logistics activities to reduce administrative burden.
Requalification Support
Support ongoing reference standard lifecycle management through stability monitoring and requalification activities.
Latest from the blog
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Safeguarding a Clinical Trial Amid Regulatory and Logistical Constraints
Expertise enabled client to proceed without delay
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Trouble with Tariffs?
On Thursday, Sept. 25, President Trump announced 100% tariffs on some imported brand-name drugs starting October 1, unless manufacturers build U.S. plants to boost domestic production. As this new tariff policy is enacted, it may have an adverse impact on pharmaceutical companies by increasing the cost of importing raw materials, drug substances and drug products, […]
Clinical Trial Materials Management Foreign-Trade Zone Warehouse & Distribution -
Generic Drug Development
Generic pharmaceuticals make up nine out of every 10 prescriptions in the United States. And in 2025, drugs for COPD, hypertension, high cholesterol, cancer, and many other disease conditions have expiring patents, so can be produced as generics. These drugs are as effective and work the same as the name brands, but typically cost consumers […]
Clinical Trial Materials Management Drug Product Synthesis & API Manufacturing
