IND-Enabling Strategy
Therapeutic development and regulatory risk reduction through comprehensive and integrated support
Comprehensive IND-enabling Lab Services
Serving as an extension of our customers’ development teams, MRIGlobal integrates expertise in drug substance and product development, analytical testing, bioanalysis, cGMP manufacturing, and regulatory to execute on their Investigational New Drug (IND) strategies. With the goal of advancing therapeutics toward IND submission, our team generates the safety, quality, and performance data required to meet regulatory expectations and efficiently transition drug candidates into clinical development.
Services to Navigate Regulatory Challenges
API & Drug Substance Preparation
Support custom synthesis and cGMP preparation of Active Pharmaceutical Ingredients (APIs).
Formulation Development
Perform pre-formulation characterization, formulation development, and stability testing according to ICH guidelines.
Regulatory Support & Consultation
Provide IND-ready materials, both drug substance and drug product, and the paperwork to align with FDA requirements.
Latest from the blog
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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 -
Demonstrating Generic Drug Equivalency
When a new pharmaceutical is in development and ready for clinical trials, the company that is producing it must file a New Drug Application (NDA). Conversely, when a generic is being produced, an Abbreviated New Drug Application (ANDA) must be filed. Through the ANDA, the manufacturer must demonstrate to the FDA that the new generic […]
Analytical Services Drug Product Pharmaceutical -
Pursuing Green Chemistry
The chemical reactions used to produce pharmaceutical drug products also produce waste. This waste is sorted by similar materials and sent to a specialized facility for treatment or disposal, which can include methods like recycling, incineration, neutralization, or stabilization, depending on the type of waste and its chemical ability. At MRIGlobal, we’re committed to producing […]
Analytical Services Drug Product Pharmaceutical
