Midwest Bio Research Drug Disposition and Toxicology Services
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Overview | Protein Bioanalysis | Small Molecule Bioanalysis | Genetic Toxicology | Program Services
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Program Services

MBR has extensive experience in managing preclinical studies and issues within multi-disciplinary project teams for both early- and late-stage drug programs. Our acquired knowledge in the pharmaceutical industry ensures clients that both their GLP-compliant and early-learning screening studies, as well as IND/CTD documents, will be expertly designed, executed, and reported to achieve successful milestones. As previous core members on internal project teams, we know how to deliver cost-effective and robust study data/reports with cycle times that optimize project timelines.

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Overview

Our capabilities include:
  • Strategic program development and program management
  • Non-clinical study design and results interpretation
  • Summary regulatory document preparation and review (IND, CTD, BLA)
  • Safety risk assessment and risk management
  • Interactions with regulatory agencies

 
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