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Fundamentally we exist for one reason: To be the trusted solution for our clients as they strive to build a better working world and improve the human experience. We are 550+ global experts that bring top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to eliminating that last punch list item and beyond, into rigorous asset management, reliability, and sustainability activities. We are your choice regardless of your location. We can support you in the US, Singapore, China, Australia, Europe, Korea, Malaysia, Vietnam and beyond. Philosophically and practically, we believe that quality, cost, and schedule can be mutually reinforcing – trade-offs are not necessary. Short-changing the focus on quality usually means problems down the road – problems that can cost money and delay the schedule. But if quality is built in from the start, then both project delivery and operational efficiency can be achieved with a much higher degree of assurance. When your project requires planned, managed, and documented high quality to exacting global standards. When you need high-performance teams on mission-critical projects. When your project is complex, high-visibility, and carries significant risk. We can help you meet a higher standard.
NLI offers: , Drug cGMP quality manufacturing processes , Superior laboratory support services following current Good Manufacturing Practices (cGMPs) , Disciplined and documented product design and engineering systems , Information-based customer
KemPharm is a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs that are designed to be improved versions of widely prescribed, approved drugs. Developing and encouraging a unique creativity, leveraged throughout the process of scientific discovery is the foundation of our corporate culture. At KemPharm we employ our Ligand Activated Therapy (LAT™) platform technology to create prodrugs that are new molecules which can improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety. We create new prodrugs by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. When combined with the parent drug, our ligands create prodrugs designed to have improved drug attributes while maintaining efficacy equivalent to the parent drug. Once administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect. KemPharm has employed its LAT™ prodrug platform to create a diverse pipeline of prodrug therapeutics that target large market opportunities in pain, attention deficit hyperactivity disorder (ADHD) and other central nervous system indications.
Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. The Company has advanced its lead candidate, resmetirom, also known as MGL-3196, a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist, through Phase 2 clinical trials in NASH. Primary and key secondary endpoints were achieved including reduction of liver fat on a sensitive non-invasive imaging test, lowering of multiple atherogenic lipids including LDL-cholesterol and triglycerides, and resolution of NASH on liver biopsy. Based on evidence of broad activity and a favorable safety profile, Madrigal has initiated a Phase 3 clinical study in NASH patients with advanced liver fibrosis, MAESTRO-NASH, in which the primary endpoint after one year of dosing is resolution of NASH and key secondary endpoints include LDL-cholesterol lowering and reduction in liver fibrosis. Clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of this trial. A second Phase 3 clinical study, MAESTRO-NAFLD-1, has also been initiated. This 52-week non-invasive study in a broader segment of NASH patients will provide additional safety information to support the NASH indication and will include key efficacy endpoints: LDL-cholesterol lowering, triglyceride lowering, reduction of liver fat as determined by MRI-PDFF, as well as reduction of elevated liver enzymes and reduction in fibrosis biomarkers. This is a non-biopsy study in people with NASH, as documented using non-invasive techniques or historical liver biopsy.
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