MPI RESEARCH – Your Responsive CRO
MPI Research with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.
Our open and responsive culture is evident in the collegial, collaborative atmosphere at MPI Research. Sponsors find communication with their counterparts within the company to be refreshingly easy, frequent, and informative. MPI Research Study Directors and scientists are uniquely accessible on a real-time basis and proactive in keeping you informed as developments unfold, from collaboration on the initial program design through final report.
A Full Spectrum of Integrated Services
With over 1 million square feet, MPI Research is the largest preclinical/early clinical single-site CRO facility in the world and has conducted thousands of drug safety, discovery, and bioanalytical and analytical studies. The company’s internal structure allows us to respond and adapt rapidly, from making last minute scheduling changes to developing new capabilities as needed. We test a wide and diverse range of compound classes, provide all routes of administration with the exception of inhalation, and offer studies with numerous species and models. With ample physical and technical capacity, we can accommodate multiple requirements simultaneously, adjust schedules readily, and produce results quickly.
MPI Research built its reputation on its toxicological experience and knowledge with small molecules. However, the company is ahead of the curve in responding to recent market trends with biotechnology-derived products, commonly known as “biologics,” or biopharmaceuticals. Our scientific experts understand the many significant ways in which the development process of a large molecule differs from that of traditional small molecules, including immune response, dose solution preparatory considerations, species-specific pharmacologic factors, and delivery methods. MPI Research has the experience and knowledge to meet all of your development needs for both large and small molecules.
Comprehensive Reporting Services
Our dedicated, experienced report coordinators partner with you and our Study Directors to design reports customized to meet your needs. With proven on-time delivery to meet IND, NDA, and submission goals for other regulatory agencies as well, our output capabilities include:
* Formatted CD-ROM option
* Tabulated summary data for CTD in draft reports when applicable
* eCTD formatting of IND/NDA submissions with infrastructure and document standards to maintain continual compliance
* FDA Electronic Submission Gateway (ECD) authorization
* Secure server for posting of confidential data and reports
The Highest Quality and Professional Standards
MPI Research is committed to excellence in quality across all services and at all levels. We are an accredited organization and operate in full compliance with international, federal, and state regulatory agencies. Our regulatory and quality assurance programs include:
* AAALAC International accreditation
* Compliance with all FDA, EPA, USDA, EMEA, OECD, ICH, and JMHW guidances and regulations
* Dedicated quality assurance, with registered QA professionals (RQAP-GLP)
* Continuous operational auditing, including subcontractors
* Ongoing customized inspection of GLP studies and reports
Please ask us about our comprehensive internal quality program, The Next Level, and Lean Six Sigma Programs, along with our many other quality-oriented and compliance initiatives.
Are you ready to go beyond with MPI research?