Zero refusals to file and a SOUL mindset helped solidify the honor
CANTON, Mich. (November 8, 2024) – Life Science Newswire – 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