Quality
Quality is of utmost importance when MPI Research conducts programs for its Sponsors. That is why MPI Research maintains a
comprehensive Quality Assurance Unit that includes experienced, well-trained and registered QA professionals (RQAP-GLP).
Our QA staff assures GLP compliance through operational audits. Current and comprehensive SOPs, which undergo rigorous
and frequent review, are key in assuring GLP compliance. All GLP studies and reports are inspected at periodic intervals
and are thoroughly audited for compliance.
Our Quality Assurance Unit also conducts facility audits of MPI Research, its divisions, and its subcontractors.
Report and Publishing
Services
Comprehensive, concise
reports are generated for all research
programs by the dedicated and experienced
Report Services department at MPI Research.
Sponsors frequently note the high-quality
of our reports, which utilize state-of-the-art
automated data collection and reporting
systems, including the use of a Xerox® docutech.
We provide an option for formatted electronic
PDF file of the report and a CTD summary
table.
To further our comprehensive service offerings,
MPI Research has added a publishing service
for increased collaboration on IND and
NDA submissions. Utilizing progressive
technology, MPI Research can now prepare
regulatory submissions in eCTD format and
has proven its ability to present technologically
compliant submissions to the appropriate
regulatory organization. For expedited
processing by the agencies, MPI Research
is authorized to send electronic submissions
via the FDA’s Electronic Submissions
Gateway (ESG). MPI Research has developed
document standards, made a significant
investment in advanced technology, and
maintains a solid base of expertise, so
that it remains in continual compliance
with the FDA’s requirement that all
electronic submissions to CDER be filed
as an eCTD.
Regulatory Experience
MPI Research is known for
its on-time delivery in meeting the IND
and NDA submission filing goals of its
Sponsors. We have substantial experience
conducting studies in accordance with
domestic and international regulatory agencies,
including: FDA, EPA, USDA, OECD, ICH, and
JMHW. Our facilities are routinely inspected
by these regulatory agencies with excellent
results that are available upon the request
of our Sponsors.
Study Process Map
Study Outlines |
