Zero refusals to file and a SOUL mindset helped solidify the honor
CANTON, Mich. (November 8, 2024) – MMS, a leading data and regulatory focused clinical research organization (CRO), today announced that its regulatory team has been selected as one of three top finalists in the Fierce CRO Awards for Leadership in Regulatory Compliance.
The Fierce CRO Awards aim
to recognize and celebrate the remarkable achievements of Contract Research
Organizations in the life sciences industry, seeking to inspire continued
innovation and help advance research and development. The Leadership in
Regulatory Compliance category recognizes CROs that demonstrate exemplary
adherence to regulatory standards and guidelines, ensuring compliance and
facilitating smooth regulatory submissions.
"Achieving finalist
status among the pharmaceutical industry’s top CROs is proof that MMS experts
are committed to helping sponsors move the industry forward, one approval at a
time," said MMS Chief Commercial Officer Ben Dudley. "This
underscores the extraordinary work that our team has accomplished to ensure
that every submission is compliant and meets or exceeds the highest agency
standards."
Where MMS regulatory
leadership stands out
MMS has set a regulatory
industry benchmark with an impeccable track record, achieving zero refusals to
file across all regulatory submissions. The company seeks to meet or exceed the
stringent standards of global health authorities to help maintain this record.
The precision,
thoroughness, and regulatory expertise that MMS brings to every project is
unmatched through full-spectrum regulatory support, from early development
consulting to lifecycle management. This includes strategic support for meeting
requests, comprehensive document preparation, and representation before global
health authorities, including the FDA, EMA, and others.
MMS has been instrumental
in helping Sponsors successfully bring more than 50 submissions to global
health authorities in the last five years. These include Investigational New
Drugs (INDs), New Drug Applications (NDAs), and Biologics License Applications
(BLAs).
Known for a data-driven
approach, MMS uses the latest regulatory intelligence tools and proprietary
platforms to streamline submissions, minimize risks, and enhance compliance
across the lifecycle of drug development. The regulatory team at MMS provides
top-tier consulting services, including expedited development strategies,
pediatric disease development, and label development for both prescription and
over-the-counter products.
The #OneMMS team made
it possible
"Our flawless track record is only possible
with the incomparable team that MMS has assembled across the globe," said
Ben Kaspar, Sr. Director of Regulatory Affairs and Strategic Consulting, MMS.
"No matter the level, our company culture that prioritizes a sense of
urgency and leadership, or SOUL as we call it, has allowed us to transcend
challenges that others may stop at."
According to Fierce, all entries were judged
on the ability of the applicant to demonstrate the following: innovation and
impact, measurable outcomes, sustainability and scalability, and ethical and
regulatory adherence.
Learn more about Regulatory solutions from MMS
at https://mmsholdings.com/solutions/regulatory-submissions/
About MMS
MMS Holdings (MMS) is an award-winning,
data-focused clinical research organization (CRO) that supports the
pharmaceutical and biotech industries with a proven, scientific approach to
complex trial data and regulatory submission challenges. Strong industry experience,
an 18-year track record, AI technology-enabled services, and a data-driven
approach to drug development make MMS a valuable CRO partner. With a global
footprint across four continents, MMS maintains an industry-leading customer
satisfaction rating.
For more information, visit www.mmsholdings.com
Media Contact Don F. McLean
dmclean1@mmsholdings.com
