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In Back-to-Back Years, MRIGlobal Named “Healthiest Employer”
For the second year in a row, MRIGlobal has been named one of the Healthiest Employers in Kansas City by the Kansas City Business Journal. Our efforts to make health and wellness a priority for our employees have been recognized in six of the last eight years. Such consistent recognition underscores our commitment to health […]
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Six Stages to Developing a Novel Infectious Disease Assay
Respiratory illnesses are generally characterized by a fever, a cough, and a sore throat. These kinds of infections are common during fall and winter and can occur in either the upper or lower respiratory tract. As the winter season gives way to spring, you may be reflecting on your own recent bouts of illness. Within, […]
Assay & Method Development Biological Threats Clinical Study Strategy & Execution -
Navigating Regulatory Challenges in Assay Development
Clear regulatory planning and early FDA engagement are critical to navigating IVD development and avoiding costly delays. Our expertise helps organizations establish the right documentation, refine study designs, and adapt to evolving FDA expectations throughout the development process.
Assay & Method Development Clinical Study Strategy & Execution Pathogen Assay Development -
Bioinformatics in Assay Development
Bioinformatics is pivotal in the development of molecular and antigen test assays for viral respiratory diseases. Its use enables a wider and deeper understanding of the viral genome and its characteristics that might be relevant to designing effective diagnostic tools. When looking at the genome of a virus, the sequence information embedded in the primer […]
Assay & Method Development Bioinformatics & Data Science - Invitro Dx RUO to IVD Product Development -
MRIGlobal Celebrates Our Scientists
Celebrate Scientists Day takes place on Thursday, March 14, coinciding with the birthday of famous physicist Albert Einstein. The day commemorates the historic and current advances and efforts of scientists who have improved the world. For more than 80 years, MRIGlobal’s scientific research and engineering contributions-from efforts in solar energy research and the fight against […]
Assay & Method Development Biological Threats Health & National Security -
In Celebration of International Day of Women and Girls in Science
Sunday, February 11, marks the ninth International Day of Women and Girls in Science (IDWGS). Established in December 2015 by the United Nations General Assembly, the IDWGS aims “to recognize the critical role women and girls play in science and technology.” According to a UNESCO science report, globally, only one in three scientific researchers is […]
Biological Threats Biologics Field-Forward Pathogen Detection -
Four Keys to Reference Standard Management
The U.S. Food and Drug Administration (FDA) defines a reference-standard material as a “highly purified compound that is well characterized.” Reference standards are a cornerstone of the pharmaceutical industry, critical to assessing product quality, safety, and potency during product development. Throughout the drug development process, properly characterized reference standards are required to ensure quality control […]
Reference Standard Management Synthesis & API Manufacturing Pharmaceutical -
Analytical Method Transfer Validation
An area of expertise that supports reference standards is analytical method transfer (AMT). When a method is developed and validated at one laboratory, research scientists at MRIGlobal then test that method to prove that it can be run at a different laboratory. With our reference standard management programs, we are often transferring methods from several […]
Analytical Services GMP Manufacturing Support Reference Standard Management -
Reference Standards in the Pharmaceutical Industry
Reliable reference standards are critical for confirming the safety and efficacy of drug substances and drug products. It is the sponsor’s responsibility to procure, qualify, and manage reference standards. In addition to a reference standard being necessary for the active pharmaceutical ingredient (API) for a particular drug, additional reference standards may also be necessary for […]
Analytical Services Reference Standard Management Pharmaceutical -
New Infectious Disease Outbreaks Around the Holidays
As families prepare to gather and then return from holiday celebrations over, a new wave of respiratory illnesses-including flu, respiratory syncytial virus (RSV), and COVID-19-has prompted outbreaks in the U.S., with 15 states experiencing a surge in infectious disease cases. To learn about how people should prepare in an effort to keep themselves and their […]
Assay & Method Development Biological Threats Product Development -
Six Questions to Ask Your CRO When Designing a Research Study
Clients often call on MRIGlobal when they know what they need but don’t know how to get there. That is why our expertise in designing pre-clinical research studies that meet the goals of our clients is so beneficial. Our Study Directors and researchers partner with our clients to establish research goals, offer guidance on how […]
Assay & Method Development Clinical Study Strategy & Execution Regulatory Strategy & Submissions -
Developing Investigational New Drug Applications
Pre-Clinical Data Supports Drug Clearance to Clinical Stage In brief, an Investigational New Drug (IND) application is like a permission slip from the FDA to initiate human testing of a new drug in the clinical stage. More technically, current Federal law requires that a drug be the subject of an approved marketing application before it […]
Drug Product IND-enabling strategy Pharmaceutical
